Friday, October 08, 2021

Pfizer immunity drops off fairly quickly

I mentioned this Kaiser Permanente study yesterday but yesterday's report did not detail the drop in immunity over time. Some reports have claimed much longer immunity from the British Astra-Zenica vaccine. That is the one I have had (with NO side effects)

Overall, vaccine effectiveness against all SARS-CoV-2 infections fell from 88% one month after receiving two doses of the vaccine to 47% six months post vaccine; however the effectiveness of the vaccine still reduced the severity of the virus further reducing the number of hospitalizations by 90%, the study showed.

Vaccine effectiveness against the Delta variant infections fell from 93% at one month after receiving the full dose to 53% four months post-vaccine, however still reduced the severity and need for hospitalization by 93%.

The findings, published Oct. 4 in The Lancet medical journal, are in line with initial reports from the U.S. Centers for Disease Control and Prevention and the Israel Ministry of Health showing declines in the Pfizer vaccine’s effectiveness against infection after about six months.

“Our study confirms that vaccines are a critical tool for controlling the pandemic and remain highly effective in preventing severe disease and hospitalization, including from the Delta and other variants of concern. Protection against infection does decline in the months following a second dose,” study lead author Dr. Sara Tartof, from the department of research & evaluation at Kaiser Permanente Southern California, said in a journal news release.

“While this study provides evidence that immunity wanes for all age groups that received the vaccine, the CDC Advisory Committee on Immunization Practices has called for additional research to determine if booster shots should be made available to all age groups eligible for this vaccine,” she noted.


Denmark, Sweden Halt Use of Moderna for Everyone Under 30

Public health officials in both Denmark and Sweden, countries which are routinely praised by the far left in America, have paused the use of Moderna’s vaccine for people under 30 years of age, citing an increased risk of heart problems associated with the COVID shot.

Both Nordic countries are commonly pointed to by so-called “democratic socialists” as models for good governance, social policies and medicine. Both countries also looked at the data and decided they would suspend Moderna’s vaccine, for now.

After reviewing research from Swedish and Nordic data sources, the Swedish Public Health Agency noted there was an increased risk for inflammatory conditions like myocarditis and pericarditis in young people who received the second Moderna shot.

“The Swedish Public Health Agency has decided to pause the use of Moderna’s vaccine Spikevax, for everyone born in 1991 and later, for precautionary reasons,” a translation of the health agency’s news release said. “The cause is signals of an increased risk of side effects such as inflammation of the heart muscle or heart sac. However, the risk of being affected is very small.”

Sweden’s health experts noted that heart inflammation issues “usually go away on their own,” but noted any symptoms “need to be assessed by a doctor.” “

“The conditions are most common among young men, in connection with, for example, viral infections such as covid-19. In 2019, approximately 300 people under the age of 30 were treated in hospital with myocarditis.

“Data point to an increased incidence also in connection with vaccination against covid-19, mainly in adolescents and young adults and mainly in boys and men. For the individual, the risk of being affected is very small, it is a very rare side effect,” the agency said.

“New preliminary [analyses] from Swedish and Nordic data sources indicate that the connection is especially clear when it comes to Moderna’s vaccine Spikevax, especially after the second dose. The increase in risk is seen within four weeks after the vaccination, mainly within the first two weeks.”

The Swedish Public Health Agency is recommending young people use the Pfizer/BioNTech vaccine if they wish. The agency will reassess the situation regarding Moderna’s shot in December.


What Merck’s Experimental COVID Pill Can and Can’t Do

The drug, molnupiravir, is named after Thor’s hammer, Mjölnir. But its power depends on reaching the right people, in the right time frame.

Two years into the pandemic, we’ve gotten a lot better at tackling the coronavirus at the extremes of infection. We have preventives—including masks, distancing, ventilation, and our MVP vaccines—that can be deployed in advance of a viral encounter. We have regimens of last resort: drugs, such as dexamethasone, that do their best, lifesaving work in hospitals with trained health-care workers, in patients whose disease has already turned severe. But in the chasm that sits in between—the hazy period after infection and before severe illness—decent tools that can derail COVID’s progression have been sparse.

We now have a new candidate aiming to fill that crucial niche: the experimental antiviral molnupiravir, developed by Merck and Ridgeback, which comes in an easy-to-swallow pill. According to a company press release posted this past Friday, the drug can halve rates of hospitalization among people recently diagnosed with mild or moderate COVID-19. Molnupiravir hasn’t yet been given emergency clearance by the FDA, and won’t be available for at least a few months, but Merck and outside experts have said they expect a formal green light soon. With the Delta variant still ravaging the world’s unvaccinated, a pill such as this one could ease the burden on overtaxed health-care systems—which most other COVID treatments have struggled to do. “To have something to take by mouth the minute you’re diagnosed, that reduces your chances of getting severely sick … that’s kind of the dream,” Nahid Bhadelia, the founding director of Boston University’s Center for Emerging Infectious Diseases Policy and Research, told me.

But in that middling stretch of the COVID timeline, molnupiravir might be able to stake out only limited territory. The drug is meant to be taken within the first five or so days of illness, “the earlier, the better,” George Painter, a pharmacologist at Emory University and one of molnupiravir’s early developers, told me. That’s a punishingly tight window, especially in nations short on diagnostics to detect the virus—as well as access to health workers and infrastructure to prescribe and provide the drug. “Rolling out an oral medication is hugely important,” Erin McCreary, a clinical pharmacist and COVID-treatment expert at the University of Pittsburgh, told me. But a pill, she said, has to be “paired with access”—of which a drug itself is no guarantee.

Despite its experimental status, molnupiravir is a pretty familiar face to the antiviral-research community. In the pre-COVID era, the drug generated some buzz when scientists found that it could stamp out a menagerie of viruses, including influenza. Its modus operandi is pretty similar to that of remdesivir, the only COVID-19 drug with full FDA approval. Both mimic building blocks of SARS-CoV-2’s genetic code, allowing them to mess with the fastidious self-xeroxing process that the virus uses to generate copies of itself inside human cells.

The two antivirals are slightly different agents of chaos, though. To make more of itself, SARS-CoV-2 deploys a scribe-like enzyme called a polymerase to scan and duplicate its genome letter by letter. When the polymerase spots a stray remdesivir molecule, it stumbles, as if flustered by a bad typo. Molnupiravir is more insidious still. It’s such a good mime of the letters in the viral alphabet that the polymerase often overlooks the interloper, making genome copies riddled with mistakes. “An analogy might be gross misspellings,” Painter said. The drug’s sabotage is so extensive that experts call it an “error catastrophe”: Dangerous viral particles have essentially no shot of emerging out the other end.

Molnupiravir’s packaging might give it another leg up. Researchers have long known that a bad case of COVID-19 tends to unfurl in two stages—one dominated by the virus, and a second by the immune system’s overzealous reaction. The point of antivirals is to act early, and fast—to nip a growing virus population in the bud, before it can wreak havoc on our tissues, or trip too many of the body’s hypersensitive alarms. These drugs are largely useless once people have descended into the second phase. Remdesivir has to be delivered intravenously, over several days—usually in a hospital, after most patients are pretty sick. (This might explain why remdesivir studies in these settings have produced mixed or underwhelming results.) Molnupiravir, meanwhile, was designed as a pill so it could be “easily administered in the outpatient setting,” Daria Hazuda, Merck’s vice president of infectious disease and vaccine discovery, told me. The drug is easily shipped and stored, and can be taken pretty much anywhere.

Merck’s recent trial, which has yet to be documented in a peer-reviewed scientific study, used the drug in people who had at least one risk factor for developing severe COVID-19 and had just begun to feel ill. Only 7 percent of them ended up getting hospitalized, compared with 14 percent in a placebo group, and none of them died. “That’s hugely clinically significant,” Ilan Schwartz, an infectious-disease physician at the University of Alberta, who wasn’t involved in the drug’s development, told me. The pill also, so far, appears to be playing nice with human cells, dealing its deathly blows only to viruses—no serious side effects have been reported yet, though Merck’s final data are expected to provide more details upon publication. And there’s been little sign that SARS-CoV-2 can evolve to skirt molnupiravir’s effects, which should make the drug relatively variant-proof. The trial’s results were so promising that an independent panel of experts evaluating the data decided to halt the study early so the company could move forward with its product.

Realistically, molnupiravir might be better compared to monoclonal antibodies—the only treatments for COVID’s early-infection phase that have gotten emergency authorization from the FDA so far. Across trials, monoclonals have proved highly effective at stopping mild and moderate cases of COVID-19 from ballooning into serious ones; some formulations have even been okayed for use in people who have recently been exposed to SARS-CoV-2 but haven’t yet developed symptoms. But monoclonals have weaknesses, too: They still need to be infused or injected by professionals, viruses can adapt to resist them, and skyrocketing demand has seriously strained supply. Molnupiravir, if it pans out, could expand the therapeutic options for this stage of disease. In a best-case scenario, the people who take it would be able to stop themselves from getting seriously sick, while also shortening the length of time the virus lingers in their body—potentially making them less of an infectious threat. Treated people could end their disease earlier in the COVID timeline.

Molnupiravir’s name, however tough to pronounce, has a story behind it. The drug’s been packing such a punch in trials, Emory’s Painter said, that it inspired him and his collaborators to name it after Mjölnir, the mythical hammer of the Norse god (and Marvel Avenger) Thor. “All we wanted was something that carried the idea of potency,” he told me, referencing Arthur C. Clarke’s The Hammer of God, a novel about a human mission to deflect an asteroid on course to collide with Earth. “That it can stop something.”

The Mjölnir reference might work in another way too. Wielding a hammer effectively requires impeccable timing. A powerful tool still needs to hit its mark.

Treatments are, by definition, reactive; a drug, no matter how early it’s dosed, can’t undo an infection, or a prior transmission event. It can only contain the fallout. The 50 percent reduction in hospitalizations noted in Merck’s press release is stellar, but some participants “still did get hospitalized,” Bhadelia pointed out, and without public data, outside researchers can’t yet identify who benefited most, or least, from the pills. Drugs such as this one might not block other outcomes, including long COVID. And Merck has yet to test the pill in pregnant people and kids. Experts also pointed out the paucity of data on the drug’s performance in vaccinated people, most of whom remain at very low risk of severe disease but could still benefit from early treatment, especially if they’re in high-risk groups. Molnupiravir won’t ever replace tools that can exert their effects before the virus even shows up. “I’m really hoping people don’t look at this as a reason to not get a vaccine,” Elizabeth Campbell, an expert in COVID antivirals at the Rockefeller University, told me.

Also, Molnupiravir is going to be used by humans, not gods. Which means it’s going to be subject to some very human limitations. For the pill to work, people will need to realize they’re sick and confirm that with a test; they will need to seek care from a health-care provider and successfully nab a prescription; they will need to access the drug and have the means to obtain it. Then they will need to take the drug successfully, which, according to Merck, means swallowing four capsules twice a day for five days—a total of 40 pills.

Molnupiravir’s been billed as a cheaper alternative to remdesivir and monoclonal antibodies, which can carry price tags of up to about $3,000 and $2,000, respectively, for the drugs alone. But at a projected $700 per course of treatment, molnupiravir still “isn’t very affordable,” Bhadelia said, especially in lower-income countries, where vaccination rates have been low and drugs like these are desperately needed. Merck has pledged to set up tiered pricing that could cut the pill’s cost abroad, and has partnered with several other manufacturers in other parts of the world to speed the timeline of availability “in maybe 100-plus countries,” Hazuda, of Merck, told me.

Even if pills were free and abundant, their effects could still be constrained by a diagnostic bottleneck. Since the pandemic’s early days, access to timely, accurate testing has been woefully inadequate, an issue that’s been exacerbated by the structural barriers faced by communities of color, Utibe Essien, a health-equity researcher at the University of Pittsburgh, told me. If a result comes too late, or a test seems out of reach, then the sick person can easily miss that crucial early-infection window—a big loss, considering that molnupiravir has essentially “no effect on patients once they’re in hospitals,” Campbell told me. “If treatment is contingent on diagnosis, we need to make sure testing is more readily available,” Essien said, or risk widening equity gaps. In this arena, in particular, molnupiravir might stand to be a bit less like its namesake: accessible only to those deemed worthy enough to wield it.




Thursday, October 07, 2021

Incredible Covid trend in Japan baffles experts as cases suddenly plummet

I think I have a fair idea of what is going on. Delta is highly infective but only for a minority of people. So once it has infected them it dies out

Despite our enjoyment of the Olympics from afar, there was a debate around whether or not the games should have gone ahead, given what was happening in Japan at the time.

The nation of 125 million had done reasonably well for a country of its size and population density before then, keeping Covid cases relatively under control and preventing deaths from the virus.

But then, almost in tandem with Australia, things started to head south in July with the introduction of the Delta strain.

It was terrible timing for Japan, with the Olympics about to bring athletes and dignitaries from all around the world into the country just as cases began to take off.

Many residents and health experts wanted the games to be called off.

Things were not looking good after athletes returned home either, as infections kept rising.

By the end of August, Japan — which has the world’s third largest economy — was clocking up more than 24,000 cases a day. Deaths began to climb too, with the seven-day average hovering around 50-60 for several weeks.

However, something truly remarkable has happened since then, and experts around the world can’t believe what they are seeing.

As other parts of Asia are seeing their cases rise, infections in Japan have plummeted to their lowest levels in nearly a year.

New daily cases in Tokyo dropped to just 87 on Monday, the city’s lowest tally since November 2 last year and a massive decline from the thousands of new cases each day seen just a matter of weeks ago.

Other cities around the nation are seeing the same trend, with the average number of daily new infections falling by more than 8000 in the past three weeks.

Experts scratching their heads

The huge decline in cases is obviously welcome news to everyday Japanese residents, but the reasons behind it are leaving experts around the world perplexed.

Professor Mark Woolhouse, epidemiologist at the University of Edinburgh, said the plunge was probably because the Delta variant appears to “move faster through populations”.

“Spikes for the Delta variant tend to be spikier. They go up faster, and they come down faster,” he told the UK’s inews.

Although the drop in cases itself is not a “particular surprise”, cases have come down “fast”, he said.

“We first saw that in the first wave of Delta which hit India and that had the same characteristic; it went up very fast, and it came down very fast,” he said.

He added that is because the Delta variant has a shorter “generation time”, meaning how long it takes one infected person to infect another.

He and government experts in Japan have put the drop in cases largely down to vaccinations and recent restrictions linked to the state of emergency.

Much of Japan has been under virus emergency measures for a large part of the year, with the restrictions finally lifting last week due to the decline in infections.

Other experts, like Kyoto University’s Hiroshi Nishiura, say the recent spike in cases has ended because of changes in the flow of people, with fewer travellers now holidaying and socialising in Japan.

Mr Nishiura believes infectivity, as measured by the effective reproduction number, is correlated with holiday breaks.

“During the holidays, we meet persons whom we seldom meet up with, and moreover, there is a substantial chance to eat together in a face-to-face environment,” Mr Nishiura, a top infectious disease modeller advising the government, told Reuters.

He said recent record cases in South Korea and Singapore may be connected to some mid-year holidays, and a convergence of Asian and Western holidays at the end of the year could lead to a “nightmare”.

Another school of thought is that the virus comes in vicious cycles, fuelled by one particular age demographic.

Jason Tetro, a Canada-based infectious disease expert and author of The Germ Code, said different age cohorts become “fuel” for the virus to spread, depending on vaccination rates and prior infections, at different times.

“Without elimination of the virus, we will continue to see spikes until 85 per cent of the population is immune to the dominant strain,” he told Reuters.
“This is the only way to get out of these vicious cycles.”

Another theory is that Covid-19 and its variants tend to move in two-month cycles, though Mr Tetro argued the cycles were “more a factor of human nature than mother nature”.

Fears as Japan heads into winter

Although cases have dropped significantly, there are fears of another wave as the nation heads into winter.

More than 60 per cent of the population is now fully vaccinated, but there are concerns that the healthcare system could easily become overwhelmed again, should a new wave emerge.

Japan’s vaccination rollout was initially slow compared to other G7 nations. Frontline health care workers were jabbed on February 17, but the rollout to older people did not start until late April.

However, Japan picked up quickly and now more than 158 million doses have been administered, with 63.5 per cent of people aged 12 and over double jabbed. That’s 57 per cent of the total population.


Pfizer and Moderna Covid vaccines were 95% effective against infection and 91% against hospitalization among US veterans - with NO deaths, study finds

Data from early this year

COVID-19 vaccines are effective at preventing infections and hospitalizations among U.S. veterans, a new study finds.

Researchers from the Department of Veterans Affairs and the Food and Drug Administration looked at data from the first three months of the shots' availability.

They found that the Pfizer-BioNTech and Moderna vaccines had an efficacy of 95 percent against infection and were 91 percent effective at preventing hospitalization.

There were also no deaths among fully vaccinated veterans.

The team says the findings shows how protective the vaccines were early on in the roll out and why it was so important to get veterans - who are a population at increased risk of severe Covid - immunized quickly.

Researchers gathered data from 6.6 million veterans between December 2020 to March 2021. They found that 1.3 million - almost one out of every five - received at least one shot of a COVID-19 vaccine during that period.

Older veterans were more likely to have received the shots at this point than their younger counterparts, though researchers found little difference in vaccination rates across racial lines.

At the time, the Covid vaccines were not available to all Americans, but instead only to certain groups depending on what state someone live in.

Seniors were prioritized in basically every state - which is why older veterans had better vaccine coverage - but veterans with certain comorbidities or who were front line workers were eligible in some states as well.

More than 472,000 participants in the study had tested for COVID-19 at some point during the study period, with 15,000 positive cases being detected.

Of the positive cases, 41 were breakthrough cases detected in fully vaccinated people, 270 were in partially vaccinated veterans and 14,799 were among the unvaccinated.

Researchers, who published their findings in JAMA Network Open on Wednesday, found that only 22.8 out of every 100,000 participants who were at least partially vaccinated in the study contracted Covid.

The rate of infection is more than ten-fold for the unvaccinated, with 280 out of every 100,000 people contracting the virus.

When adjusting for other factors, such as age, race and geography, researchers found that the vaccine is 95 percent effective at preventing infection, and 91 percent effective at preventing hospitalization.

There were also no COVID-19 deaths among fully vaccinated participants in the study.

Partial vaccination - meaning receiving only one shot of a two-dose series - still provides protection as well with 64 percent vaccine effectiveness against infection.

One shot was also 48 percent effective at preventing hospitalization and 63 percent effective at preventing deaths, the researchers found.

While the results of the study do capture the initial effectiveness of the Moderna and Pfizer-BioNTech vaccines, the situation in America has changed since data was captured.

The Delta variant, a highly contagious strain of the virus that caused a massive surge of cases in the U.S. over the summer, had not yet reached the nation in March.

More recent data also shows that the vaccine's effectiveness at preventing infection does wane over time, meaning the earliest adopters of the shots - who would be among those vaccinated seven months ago - will not be as protected now as they were then.

In order to combat the waning effectiveness, booster shots have been made available to people over the age of 65 or with comorbidities that put them at serious risk from the virus.

Currently in the U.S., 65 percent of people have received at least one dose of a COVID-19 vaccine and 56 percent of residents are fully vaccinated.

Just over six million booster doses have been administered as well, according to official data.




Covid cases plunge after Norway abruptly gets rid of all restrictions

The autumnal drizzle is falling on Norway and the days are getting shorter but if you were able to take a walk along the streets of Oslo, you would feel as if you’re in an alternate reality to our lives at home.

There are no masks in sight, no talk of vaccine passports, no social distancing markers on the ground and people are meeting their family and friends for a meal, a movie or concert.

The only indication that the pandemic ever happened is that there are a couple of Covid testing facility cabins at public places where staff wear face masks.

Other than that, Norwegians have reclaimed their lives after the last of their Covid restrictions were confined to the dustbin last week.

There were rowdy celebrations over the weekend with dozens of disturbances and violent clashes including mass brawls in Norway’s big cities after streets, bars, restaurants and nightclubs were filled with people celebrating the end of restrictions that lasted for more than a year.

It came after the government there abruptly announced on Friday that most of the remaining coronavirus restrictions would be scrapped beginning on Saturday and that life in the nation of 5.3 million would return to normal.

The announcement by outgoing Prime Minister Erna Solberg took many Norwegians by surprise – and is perhaps one of the reasons there were such chaotic scenes in the capital, Oslo, and elsewhere in the country.

“It has been 561 days since we introduced the toughest measures in Norway in peacetime,” Ms Solberg said on Friday at a news conference. “Now the time has come to return to a normal daily life.”

But the best news of all is that Covid cases and deaths there are dropping at a rapid rate even though the rules have been eased — following a similarly positive trend in neighbouring Nordic nations that have also scrapped all Covid rules.

And, despite their dismal weather, the Scandinavian countries that have done away with their rules are performing far better in avoiding deaths than many other developed nations.

Any fears of a rise in cases since the reopening in Norway have been slapped back by the early indications in infection numbers.

Cases have plummeted 40 per cent in the short time that Norway has reopened and new daily cases have dropped by 50 per cent over the last two weeks.

And, unlike many other nations that are reopening, Norway will not order its citizens to show proof of vaccination or a negative test result to enter nightclubs, bars and restaurants.

Sixty-seven per cent of the population are fully vaccinated and a further 10 per cent have had a first dose, according to the Our World in Data project at the University of Oxford.

Norway is one of three Nordic nations that has scrapped all Covid rules in the past few weeks – along with Sweden and Denmark.

Denmark lifted all of its restrictions two weeks prior to Norway’s announcement. The government there also no longer requires digital proof of vaccination to enter nightclubs, saying the virus is no longer “a socially critical disease”.

“This can only be done because we have come a long way with the vaccination rollout, have a strong epidemic control, and because the entire Danish population has made an enormous effort to get here,” Denmark’s Health Minister Magnus Heunicke said.

Around 75 per cent of the Danish population is fully vaccinated with at least 77 per cent having received at least one dose. The fully vaccinated include around 96 per cent of people who are over 50 years old, according to the Foundation for Economic Education.

Interestingly, cases have also dropped by 40 per cent since restrictions were lifted three weeks ago.

Meanwhile, Sweden – which had been criticised for not going hard on restrictions early on in the pandemic and has not prevented as many cases or deaths as Denmark and Norway – is performing better than most Western nations after dropping restrictions six days ago.

Sweden’s death rate from the virus of 1462 confirmed deaths per million is much higher than that of both Denmark and Norway, where deaths number 457 per million and 156 per million respectively, according to Our World in Data.

However, Sweden’s death rate is lower than several Western countries, including Spain, with 1847 deaths per million; Britain at 2005, the US at 2080, and Italy at 2167.

Daily Covid deaths are also low in all three Nordic nations that have scrapped restrictions.

According to Our World in Data, Sweden saw approximately nine confirmed deaths in the most recent seven-day rolling average, while Norway saw one death and Denmark three deaths. Adjusting for population, that’s 0.84, 0.26, and 0.47 deaths per million, respectively.

However, as jabs roll out worldwide, there is a positive trend emerging globally.

The weekly number of coronavirus deaths worldwide has fallen to levels unseen for almost a year at an average of 7606 each day, according to an AFP count based on official national figures.

By their count, coronavirus has killed at least 4,798,207 people since the outbreak emerged in China in December 2019.

The US is the worst-affected country with 701,176 deaths, followed by Brazil with 597,948, India with 448,997, Mexico 278,801 and Russia 210,801.

Based on latest reports, the countries with the most new deaths were Russia with 883 new deaths, followed by the US with 246 and Iran with 229.


AstraZeneca launches new drug to prevent COVID symptoms

COVID-19 vaccine maker AstraZeneca has applied for emergency approval in the US of a new coronavirus-fighting drug that could provide another therapeutic option.

The pharmaceuticals giant confirmed overnight it has lodged an application with the US Food and Drug Administration to approval its AZD7442, a “long-acting antibody” drug designed to prevent symptoms of the virus before an individual is exposed to COVID-19.

The drugmaker says the antibody cocktail, which is injected into the veins, could be used to protect people who have had a coronavirus vaccine but may not have mounted a strong immune response to the virus because they are immuno-compromised.

Early data from a phase 3 study of the product showed that the treatment reduced the risk of developing a symptomatic case of COVID-19 compared to a placebo.

If the product is approved in the US, it would be the first treatment of its kind to get the green light. The company said it was already open for talks about supply agreements around the world.

“Discussions regarding supply agreements for AZD7442 are ongoing with the US government as well as other governments around the world,” AstraZeneca said in a statement.

Australia has spent the past month upping its arsenal of COVID-19 therapeutics, including increasing its orders for GSK’s early intervention IV treatment and buying 300,000 doses of Merck Sharp & Dohme’s experimental antiviral pill Molnupiravir.

On Tuesday, the Australian regulator also granted a “provisional determination” to Pfizer for its COVID treatment, which paves the way for Pfizer to submit full data for consideration.

Pfizer launched a study of the drug in 2,660 patients last week. Its treatment is designed as a pill that is taken over five days at the first sign of infection or awareness of exposure to the virus, acting to block the activity of the enzyme the virus uses to replicate.

AstraZeneca’s vice-president of biopharmaceuticals R&D, Mene Pangalos, said products like AstraZeneca’s treatment will hopefully act as an additional option to protect against the virus, along with vaccines.

“Vulnerable populations such as the immuno-compromised often aren’t able to mount a protective response following vaccination and continue to be at risk of developing COVID-19,” Mr Pangalos said


Pfizer COVID-19 Vaccine’s Effectiveness Falls Below 50 Percent After 5 Months: Study

According to a new study published in The Lancet medical journal on Oct. 4.

The study (pdf), which was funded by Pfizer, aimed to evaluate the overall variant-specific effectiveness of the companies’ vaccine against CCP (Chinese Communist Party) virus infections and COVID-19-related hospital admissions over time.

Researchers analyzed electronic health records of more than 3.4 million men and women who were members of the health care organization Kaiser Permanente Southern California between Dec. 14, 2020, and Aug. 8, and assessed the vaccine effectiveness up to six months after they were inoculated.

They found that the Pfizer vaccine was 88 percent effective in the first month after full vaccination, but dropped to 47 percent effectiveness after five months.

The vaccine was also found to be highly effective against the Delta variant, providing 93 percent effectiveness in the first month after full vaccination but declining to 53 percent after four months.

By comparison, effectiveness against other non-Delta variants was 97 percent after a month and declined to 67 percent after four to five months, according to the study.

Effectiveness against Delta-related hospital admission remained high at 93 percent for up to six months, the researchers said.

Researchers said that the reduction in effectiveness was likely because of waning immunity over the period of time since the individual was given the second shot as opposed to the Delta strain.

“Our results provide support for high effectiveness of BNT162b2 against hospital admissions up until around six months after being fully vaccinated, even in the face of widespread dissemination of the Delta variant,” the researchers wrote.

“Reduction in vaccine effectiveness against SARS-CoV-2 infections over time is probably primarily due to waning immunity with time rather than the Delta variant escaping vaccine protection.”

“Our results reiterate in a real-world U.S. setting that vaccination with [the Pfizer-BioNTech COVID-19 vaccine] remains an essential tool for preventing COVID-19, especially COVID-19-associated hospital admissions, caused by all current variants of concern,” they added.

The latest Pfizer-funded study comes one day after a separate BioRxiv study published on Oct. 4 that found that antibody levels generated by two shots of the Pfizer-BioNTech vaccine can undergo up to a 10-fold decrease seven months following the second vaccination.

The research, which is yet to be peer-reviewed, noted that the drop in antibody levels would compromise the body’s ability to defend itself against COVID-19 if an individual becomes infected.

The study focused on 56 healthy participants who had received two doses of the Pfizer-BioNTech vaccine. The participants’ blood was tested once after receiving the second vaccination and once again after six months.

Researchers suggested administering a third booster shot as a measure to improve vaccine efficacy.

Both studies reiterate findings from Pfizer and BioNTech that were released in July showing that vaccine effectiveness dropped from 96 percent to 84 percent over six months.

The Pfizer-BioNTech vaccine is the most widely used in the United States. More than 226 million doses have been administered as of Sept. 30, compared with 151 million Moderna shots and 15 million of the Johnson & Johnson vaccine.




Tuesday, October 05, 2021

Pfizer's COVID-19 vaccine is more than 90% effective against hospitalization from all variants - including Delta - for first six months after receiving shots

Pfizer-BioNTech's COVID-19 vaccine remains effective at preventing hospitalizations for at least six months, a new study suggests..

Researchers at Kaiser Permanente Southern California (KPSC) gathered data from the company's health care network to discover how often fully vaccinated people were either testing positive for the virus or being hospitalized because of it.

They found the Pfizer vaccine was 90 percent effective at preventing hospitalizations for the first six months after becoming fully vaccinated.

Existing variants also seem to have little ability to bypass the vaccines, including the highly transmissible Delta variant, which is now responsible for nearly all cases in the U.S.

The vaccine's effectiveness at preventing infection does significantly wane over time, though, falling as low as 47 percent after five months.

Previous studies have had similar findings regarding the effectiveness of the Covid vaccines at preventing infection and hospitalization.

The results of the study show that a recent uptick in breakthrough cases may have less to do with any factors specific to the Delta variant, but instead have to do with the efficacy of the vaccines falling over time.

These breakthrough cases are less serious, though, with the vaccine still showing the ability to prevent hospitalizations and death.

'Our variant-specific analysis clearly shows that the [Pfizer] vaccine is effective against all current variants of concern, including Delta,' said Dr Luis Jodar, senior vice president of Pfizer Vaccines, in a statement.

'COVID-19 infections in people who have received two vaccine doses are most likely due to waning and not caused by Delta or other variants escaping vaccine protection.'

For the study, published in The Lancet, the team gathered data from 3.4 million members of the KPSC health network.

They analyzed health records to find how often people tested positive or required medical treatment due to the virus.

People whose data was included in the study were separated by age to find any potential differences in vaccine effectiveness over the six months following the second jab.

Researchers found little differences among age cohorts in both the ability to prevent hospitalizations or infection.

Among all age groups, the vaccine's effectiveness slowly declined over the months, eventually falling to around 50 percent.

Overall, the vaccine showed 73 percent effectiveness at preventing infection during the first six months after vaccination.

Effectiveness against hospitalization remained stable for all ages, showing little change over the first six months.

Other studies have made similar findings, including a Mayo Clinic study from August that found the Pfizer vaccine is only 42 percent effective at preventing infection in July, though still 75 percent effective at preventing hospitalization.

At the time, it was believed that the Delta variant was the cause for declining efficacy, though the KPSC findings state otherwise.

Another study from the Centers for Disease Control and Prevention also found that efficacy of the Pfizer vaccine declined to around 50 percent over time.

The findings match what many health officials have said in recent weeks in conversations regarding Covid booster shots.

The White House, wanted to roll out boosters for all Americans starting on September 20, citing the waning efficacy of the vaccines as the reason for the third shots.

Some officials and experts disagreed, including 18 senior Food and Drug Administration (FDA) officials who published a report opposing the boosters last month, instead cite the vaccine's effectiveness at preventing hospitalizations as a reason why the boosters are not needed.

The FDA declined to authorize the boosters for all Americans over the age of 18, instead only giving authorization for the Pfizer boosters to be used for Americans aged 65 or older or with a comorbidity that makes them vulnerable to the virus.

Eligible Americans quickly took advantage of the boosters availability, with nearly two million of the shots being administered last week, the White House reported.


Safe to receive Covid and flu jabs at the same time, study shows

Research also finds that co-administration has no negative impact on immune response generated by both vaccines

It is safe for people to receive a dose of the Covid and flu vaccine at the same time, new research shows, and nor is there any negative impact on the immune response as a result of co-administration.

Scientists behind the Combining Influenza and Covid-19 Vaccination (ComFluCov) study said their findings support government plans to roll out Covid booster jabs alongside flu shots, where it is deemed practical.

A trial led by a team at the University of Bristol showed that the reported side effects of co-administration were mainly mild to moderate, concluding that “concomitant vaccination raises no safety concerns and preserves the immune response to both vaccines”.

Dr Rajeka Lazarus, a consultant in infectious diseases and microbiology, and chief investigator for the ComFluCov study, said the research demonstrated that “it is possible to protect people from both Covid-19 and flu at the same appointment”.

She added: “This is a really positive step which could mean fewer appointments for those who require both vaccines, reducing the burden on those who have underlying health conditions and would usually be offered the influenza vaccine.

The results of the study, which has yet to be peer-reviewed, have already been shared with the the Joint Committee on Vaccination and Immunisation and the UK’s medicines regulator.

They were used to help shape preparations for the autumn and winter plan. Under this, more than 50 million Covid booster jabs are to be offered, while some 30 million flu shots will also be rolled out.

As part of the ComFluCov trial, two Covid and three flu vaccines were tested – six combinations in all.

Study participants were over the age of 18 and had already received one dose of either the Pfizer/BioNTech or the Oxford/AstraZeneca jab, and were awaiting their second dose.

A total of 679 volunteers took part in the study across 12 NHS sites in England and Wales.

One group received their second dose of the Covid vaccine and the flu vaccine at their first study visit, then a placebo at their second visit.

A second group received their second dose of the Covid-19 vaccine and a placebo at their first visit and then the flu vaccine at their second visit.

Participants also attended a third study visit to discuss any side effects and give a blood sample.

The most common side effects were pain around the injection site and fatigue.

Some combinations saw an increase in the number of people who reported at least one side effect when both Covid-19 and flu vaccine were given together, but the reactions were mostly mild or moderate, researchers found.

According to the study, the immune responses to both the flu and Covid-19 vaccine were preserved when given together, and 97 per cent of participants said they would be willing to have two vaccines at the same appointment in the future.

Professor Andrew Ustianowski, clinical lead for the Covid-19 vaccination programme at the National Institute for Health Research (NIHR), said: “This research has quickly provided important and reassuring results that could make vaccination more efficient for both patients and the NHS.”

The study was led by researchers at the Bristol Trials Centre at the University of Bristol and University Hospitals Bristol and Weston NHS Foundation Trust, and supported by the Clinical Research Network West of England.

Dr Peter English, a former chair of the BMA Public Health Medicine Committee, said “there is a long history of vaccinating people against more than one disease simultaneously”.

He added: “I cannot think of any examples where co-administration of vaccines is in any way unsafe.

“We would not expect any problems to arise from co-administration of flu and Covid-19 vaccines; but it is wise and precautionary to check for possible problems in clinical trials before authorising or recommending widespread co-administration. This study does just that.”



WaPo runs interference for Biden, gives him just 2 Pinocchios for the “zero dollars” whopper (Washington Post)

“We can get you out of office if you don’t support what you promised us”: Kyrsten Sinema pestered by immigration activists (Fox News

Dems tuck multibillion-dollar handout to illegal immigrants into reconciliation (Free Beacon)

Friendly fire: House Democrats blast Nancy Pelosi after spending bills holdup (New York Post)

Dr. Anthony Fauci isn’t sure that you can gather for Christmas, but he is sure that you must give up your individual rights (American Thinker)

CDC implements gun violence study after wrongly naming it a “public health threat” (PM)

No joke: Catch-and-release at border up more than 430,000% in August (Washington Times)

Havana Syndrome continues to baffle U.S. officials (Washington Times)

Woke infighting: Women’s March cancels “Handmaid’s Tale” imagery over its use by white women (PM)

Facebook whistleblower trashes the social media giant on “60 Minutes” ahead of her congressional testimony (New York Post)

Seven of the 10 states in worst financial condition are run by Democrats (Just the News)

Self-proclaimed shaman accused of starting California fire said she was trying to boil bear urine (Washington Examiner)




Monday, October 04, 2021

First Covid test which can detect the virus from a saliva swab will be rolled out across the UK

The KnowNow antigen test mimics the surface of a human cell to identify the virus and only recognises 'infectious' or 'active' Covid.

By comparison, PCR and lateral flows are susceptible to picking up 'harmless viral fragments' - meaning some people test positive and have to isolate despite not having the virus.

The test is designed to mimic the experience of brushing your teeth rather than sticking a swab up the nose and swiping the back of the throat, and is more accurate than its predecessors.

A spokesman said: 'KnowNow enables testing to keep people safe, whilst minimising disruption, increasing trust and keeping society and the economy open.'

While currently registered in Britain and the EU and undergoing clinical trials, it is yet to be screened across the US.

Vatic Health Limited, a UK based health-tech company, has today signed the supply agreement with one of the largest manufacturers of lateral flow tests in Europe, Abingdon Health.

Together, they hope to roll out up to 100 million of the KnowNow Covid tests every year.

Alex Sheppard, co-founder of Vatic, said: 'We are now moving into a new phase where the pandemic as we know it is over, and now we are having to deal with disruptions as we learn to live with the virus.

'Unfortunately with the rise of several mutations across the world, vaccinations alone are not the total solution.

'Regular testing technologies are needed to help reduce the overall spread and keep the economy back up and running.

'Our unique test technology, combined with a UK-based manufacturing roll-out is a major milestone in testing.

'With the potential to manufacture two million tests per month initially, and significantly more beyond this as we scale, this deal will help us ensure the hard-fought wins around societal reopening are retained and we can really make a global impact.

'Covid-19 testing will remain alongside booster vaccinations, a key pillar of our collective biosecurity.'

Chris Yates, Chief Executive Officer of Abingdon Health, commented: 'We are delighted to be working with Vatic on the technology transfer of their cutting edge Covid-19 test into Abingdon Health and to have secured this long-term manufacturing arrangement.

'We expect to have concluding tech transfer shortly and having already completed the first phase of the expansion of our manufacturing capacity, we are now at the forefront of Covid-19 rapid testing and part of the UK's diagnostic manufacturing capacity.

'The agreement with Vatic is testament of our ability to provide high-quality services for our partners, whether for Covid-19 tests or non-Covid assays.'


The booster effect? Israel's Covid infections plummet nearly THREE-FOLD in a fortnight and hospital admissions drop by a third

Coronavirus cases are plummeting in Israel for the first time in months and hospital admissions are now firmly in retreat — in a sign of the booster jab programme taking effect.

The country is recording on average fewer than 4,000 Covid infections each day now compared to 11,000-plus at the peak of its third wave on September 14, which was more than at any other point in the pandemic.

Cases have been in freefall now for weeks despite Israeli schools returning from the summer break this month and record numbers of tests being deployed in classrooms.

It puts an end to a meteoric rise in infections in recent months that was believed to be due to waning immunity and the rise of the exceptionally infectious Delta variant.

Israel launched its trailblazing booster jab programme in July in response to the rising wave, which initially targeted over-60s before expanding to everyone aged 12 and above who had been double-dosed.

The number of people being admitted to hospital with the virus each week has been falling for the past month, in what Israeli scientists believe is the result of heightened immunity from the third dose.

Stats compiled by Oxford University-based research team Our World in Data shows there were 110 admission per million people in the week up to September 26, the most recent date, compared to about 165 per million on August 29.

Britain last week launched its own booster vaccine programme, with more than 30million people aged 50 and over, frontline medics and carers and patients with weak immune systems in line for a third jab.

Data from Israel suggests a booster shot slashes the risk of infection by 11 times less and makes people up to 20 times less likely to need hospital care.

A major study published New England Journal of Medicine (NEJM) on September 15 found that over-60s given a third dose were 11.3 times less likely to become infected with Delta two weeks after the booster.

The research looked at more than 1.1million Israelis. It also found that people given a booster were 19.5 times less likely to be hospitalised with Covid than those who were still relying on protection from two doses.

Britain's Covid outbreak has shrunk for the first time in nearly two weeks, while hospital admissions and deaths continue to drop.

Another 36,480 positive tests were recorded across the UK on Thursday, down 0.6 per cent on the 36,710 infections spotted last week.

Week-on-week cases had been rising steadily for the previous 12 days.

Despite the fall in official numbers, it could be a blip because other surveillance measures today revealed cases are still rising.

King's College London data today showed the number of Britons catching Covid every day rose almost 30 per cent last week.

Cases have soared in children ever since millions of youngsters returned to classrooms following the summer holidays. But now infections appear to be spilling over into their parents, a trend MailOnline revealed earlier this week.

Meanwhile, Covid hospitalisations and deaths continued to fall, with 657 people infected with the virus requiring NHS care (down by 12 per cent on last week) and 137 fatalities recorded (down by a quarter).

Both figures lag several weeks behind infections because of how long it can take for infected patients to become seriously ill.

Latest data from the country's health ministry suggests that the booster programme is creating strong protection in the elderly.

The rate of severe Covid illness in over-60s is currently nine times higher among those who have had two vaccine doses compared to the triple-jabbed — on September 25 it was 36 per 100,000 in the two dose group compared to just four per 100,000 in the booster group. Among those who are completely unvaccinated, the rate was 170.

The results in Israel have not yet convinced the UK's health officials to recommend a mass booster campaign for younger age groups.

No10's vaccine advisory panel, the Joint Committee on Vaccination and Immunisation (JCVI), believes younger people had higher immunity from two doses because of the UK's unique dosing strategy.

While Israel, the US and many other nations spaced the two doses three weeks apart, Britain extended this to three months.

At the time that decision was made, at the height of the second wave, it was to get more jabs in more arms in the hope that partial protection for many rather than full protection for some would drive down the epidemic.

Studies later showed that the wider gap generated stronger and longer lasting immunity.

Britons are only being invited to come forward for a booster if they had their second jab at least six months ago, which officials said was the 'sweet spot' for boosters.

Third doses will be rolled out to the top nine priority groups during the initial drive, with the elderly, medics and carers first in line again.

Doses of the Pfizer jab, or a half dose of Moderna, will be administered as boosters, regardless of which jab they initially received, because studies showed they were the most effective at topping up immunity.

For those who cannot get either of those two mRNA jabs, such as due to an allergy, they will be given a dose of AstraZeneca's vaccine. A half dose of Moderna has been chosen because it was found to have fewer side effects but similar efficacy.

The UK also started vaccinating healthy 12 to 15-year-olds for the first time last week with the hope of keeping the epidemic at bay and preventing school closures this winter. They are being offered a single dose of Pfizer for now.

Officials have not yet released data on how many Britons have received third doses of the vaccine or how many 12 to 15-year-olds have received their first injection, despite both programmes beginning earlier this month.

It comes after Britain's Covid outbreak shrunk for the first time in nearly two weeks yesterday.

Another 36,480 infections were recorded across the UK, down 0.6 per cent on the number last Thursday. Week-on-week cases had been rising steadily for the previous 12 days.

Cases have soared in children ever since millions of youngsters returned to classrooms following the summer holidays. But now infections appear to be spilling over into their parents, a trend MailOnline revealed earlier this week.

Meanwhile, Covid hospitalisations and deaths continued to fall, with 657 people infected with the virus requiring NHS care (down by 12 per cent on last week) and 137 fatalities recorded (down by a quarter).

Both figures lag several weeks behind infections because of how long it can take for infected patients to become seriously ill.




Sunday, October 03, 2021

People not fully vaccinated against Covid are 57 TIMES more likely to die and 41 times more likely to be hospitalized due to spread of the Delta variant, Fauci says

The nation's top infectious diseases expert said Americans who are not fully vaccinated against COVID-19 are several times more likely to be hospitalized or die.

During a White House COVID-19 Response Team press briefing on Friday, Dr Anthony Fauci shared data on virus outcomes by vaccination status from Public Health - Seattle & King County in Washington state.

The data found individuals who had not started or completed their vaccine series were eight times more likely to test positive for Covid.

These people were also 41 times more likely to be hospitalized due to the virus and 57 times more likely to die than those were fully vaccinated.

Fauci said that because these figures are from the past month, this shows how highly transmissible the Delta variant is and how protective vaccines are against the most severe effects of Covid. 'This is COVID-19 data over the past 30 days - essentially Delta data,' he said.

'COVID-19 vaccines are safe, effective, convenient and free. They protect you, your loves ones, and your community.'

The data compared King County residents with 'breakthrough cases,' which occur when people test positive for Covid at least 14 days after receiving their final dose, to unvaccinated people who contract the virus.

Officials have previously stated that no vaccine provides 100 percent protection, which means there will be more breakthrough cases as more people get vaccinated.

However, studies have shown that less than one percent of people who are fully vaccinated contract the virus, and even fewer have severe complications.

As of September 20, the most recent date for which Centers for Disease Control and Prevention (CDC) data is available, 14,643 out of more than 181 million fully vaccinated people were hospitalized. An even smaller number - 4,493 - died.

The new data, compiled by King County officials, show just how uncommon breakthrough infections are and how protective COVID-19 vaccines are against critical illness.

Fully vaccinated residents were compared to 'not fully vaccinated' people - meaning the unvaccinated, people who just started their vaccine series and those who completed vaccination within the last 14 days.

Results showed that, over the last 30 days, 11,868 not fully vaccinated people tested positive for Covid compared to 5,640 fully vaccinated residents.

The daily case rate for fully vaccinated people was 10.7 new cases per 100,000 people compared to 82.4 per 100,000 among the not fully vaccinated.

This means that people not fully vaccinated were 7.7 times more likely to contract the virus. When it came to hospitalizations and deaths, the risk was even higher among not fully vaccinated individuals.

Over the last month, 543 not fully vaccinated residents were hospitalized with a rate of 8.72 per 100,00 per day.

Comparatively, 131 people who completed their immunization series were hospitalized with a daily rate of 0.21 per 100,000 per day - meaning the fully vaccinated were 41.4 times less likely to need inpatient care.

During the same time period, 90 not fully vaccinated individuals died as did 26 fully vaccinated people.

With a daily case rate of 2.28 deaths per 100,000 for the not fully vaccinated compared to 0.04 per 100,000 for the fully vaccinated, it means those who have not started or completed their vaccine series are 56.7 times more likely to die of Covid.

Because these cases, hospitalizations and deaths occurred over the last month, Fauci said these are linked to the Delta fueled-surge.

A report last week from the state Department of Health showed that, as of September 11, all virus samples that underwent genetic sequencing were confirmed to be Delta, meaning the variant is essentially responsible for 100 percent of all infections.

The variant is at least twice as contagious as previous dominant strains including the Alpha variant, which originated in the UK.

'We are extremely concerned by this increased spike in cases, driven by the delta variant, spreading like wildfire amongst men, women, and children,' Washington's Secretary of Health Dr Umair Shah said last month.

'Vaccination the best tool we have in this pandemic, but we also recommend that individuals mask indoors, and avoid large, crowded settings vaccinated or not.'


Pfizer no better than AstraZeneca long term, UK study finds

Over 60s holding out for the Pfizer Covid jab are in for a harsh reality check — it is no better than the AstraZeneca jab they could have got months ago in long-term efficacy.

A new study shows after four months, both vaccines provide similar protection against the virus.

The large UK study found the efficacy of the Pfizer jab fell by 22 per cent per month — from an original 84 per cent for adults overall — and after four and a half months it had around the same effectiveness against the Delta strain as AstraZeneca.

AstraZeneca’s efficacy began at 69 per cent for adults overall a fortnight after the second dose, before falling to 61 per cent after 90 days, the study by the University of Oxford, the UK Office for National Statistics and the UK Department for Health and Social Care (DHSC) found.

“Extrapolating declines beyond the observed follow-up, both vaccines would be equally effective against PCR-positives with (4.6 months) after the second dose and 116 days (3.8 months) against PCR-positives with symptoms,” the study found.

The study has not yet been peer reviewed by other experts or published in a medical journal, so the findings must be treated with caution.

Both vaccines were much more effective against Delta in younger people and provided stronger protection if the person had contracted Covid as well as being vaccinated, the study found.

Pfizer was 90 per cent effective against Delta in those aged 18-34 years versus 77 per cent for those aged 35-64 years.

AstraZeneca was 73 per cent effective in people aged 18-34 years and only 54 per cent effective in people aged 35-64 years.

Overall the third vaccine option, Moderna, holds its efficacy for at least six months, other studies show.

University of Newcastle, Australia immunologist Professor Nathan Bartlett AstraZeneca said the UK study showed “AstraZeneca is an excellent vaccine. It’s always been comparable to the Pfizer vaccine in terms of protection against severe disease.”

“There is early evidence to suggest that maybe AstraZeneca does confer a little bit longer, or you know, the waning is a little less rapid than Pfizer but it’s not a huge difference and we don’t know whether or not that’s important. In the long run I think we’re still going to need boosters,” he said.

More important than protection against infection was the fact both vaccines were equally good at preventing hospitalisation and death, he said.

Australian National University infectious diseases expert Professor Peter Collignon said there had been vaccine snobbery in Australia with some people shunning the AstraZeneca jab.

“I haven’t said too much but I thought, won’t it be ironic if the AstraZeneca ended up giving you a better prediction than Pfizer over six to 12 months. We don’t know at the moment but it may actually,” he said.


Merck’s COVID-19 pill cuts risk of death, hospitalisation by half in study

Merck & Co Inc’s experimental oral drug for COVID-19, molnupiravir, reduced by around 50 per cent the chance of hospitalisation or death for patients at risk of severe disease, according to interim clinical trial results announced on Friday.

Merck and partner Ridgeback Biotherapeutics plan to seek US emergency use authorisation for the pill as soon as possible, and to submit applications to regulatory agencies worldwide. Due to the positive results, the Phase 3 trial is being stopped early at the recommendation of outside monitors.

“This is going to change the dialogue around how to manage COVID-19,” Robert Davis, Merck’s chief executive officer, said.

If authorised, molnupiravir, which is designed to introduce errors into the genetic code of the virus, would be the first oral antiviral medication for COVID-19.

Rivals including Pfizer Inc and Swiss pharmaceutical Roche Holding AG are racing to develop an easy-to-administer antiviral pill for COVID-19 but so far, only antibody cocktails - which have to be given intravenously - are approved for treating non-hospitalised COVID-19 patients.

A planned interim analysis of 775 patients in Merck’s study found that 7.3 per cent of those given molnupiravir were either hospitalised or had died by 29 days after treatment, compared with 14.1 per cent of placebo patients. There were no deaths in the molnupiravir group, but there were eight deaths of placebo patients.

“Antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” Wendy Holman, Ridgeback’s CEO, said.

In the trial, which enrolled patients around the world, molnupiravir was taken every 12 hours for five days.

The study enrolled patients with laboratory-confirmed mild-to-moderate COVID-19, who had symptoms for no more than five days. All patients had at least one risk factor associated with poor disease outcome, such as obesity or older age.

Merck said viral sequencing done so far shows molnupiravir is effective against all variants of the coronavirus, including highly transmissible Delta.

The company said rates of adverse events were similar for both molnupiravir and placebo patients, but did not give details of the side effects.

Merck has said data shows molnupiravir is not capable of inducing genetic changes in human cells, but men enrolled in its trials have to abstain from heterosexual intercourse or agree to use contraception. Women of child-bearing age cannot be pregnant and also have to use birth control.

Merck said it expects to produce 10 million courses of the treatment by the end of 2021, with more doses coming next year.

The company has a US government contract to supply 1.7 million courses of molnupiravir at a price of $700 per course.

CEO Davis said Merck has similar agreements with other governments worldwide, and is in talks with more. The company said it plans to implement a tiered pricing approach based on country income criteria.

Merck has also agreed to license the drug to several India-based generic drugmakers, which would be able to supply the treatment to low- and middle-income countries.

Molnupiravir is also being studied in a Phase 3 trial for preventing coronavirus infection in people exposed to the virus.

Merck officials said it is unclear how long the FDA review of the drug will take. “I believe that they are going to try to work with alacrity on this,” said Dean Li, head of Merck’s research labs.