Sunday, February 28, 2021

FDA Panel Recommends Johnson & Johnson's One-Dose COVID Vaccine for Approval

More good news on the coronavirus front. A panel of FDA advisors voted unanimously on Friday to recommend the agency approve drugmaker Johnson & Johnson's one-dose coronavirus vaccine in the United States. Following the recommendation by the FDA’s Vaccines and Related Biological Products Advisory Committee, the FDA is expected to approve the vaccine for emergency use in the coming days.

Johnson & Johnson's vaccine will be the third coronavirus vaccine to receive FDA approval, but the first vaccine requiring just one shot for vaccination. The drug showed a 66 percent effectiveness against moderate to severe COVID-19 infections and about an 85 percent effectiveness against the most serious illnesses. While two other FDA-approved vaccines have efficacy rates in the 90s, Johnson & Johnson's drug was shown to prevent 100 percent of hospitalizations in a clinical study of around 44,000 participants in the United States.

"This is a vaccine to prevent you from going to the hospital and dying at a level that’s certainly comparable" to the Pfizer and Moderna vaccines, said Dr. Paul Offit, a member of the FDA's advisory panel and vaccine expert at Children's Hospital of Philadelphia.

Unlike the vaccines developed by Pfizer and Moderna, Johnson & Johnson's vaccine candidate does not to be stored in freezers and remains stable for months in refrigerated temperatures.

In the United States, over 44 million Americans have received at least one dose of the two-dose vaccines developed by Pfizer and Moderna, according to the AP. Nearly 20 million Americans have now received both doses.

Around 3 to 4 million doses of the new vaccine are expected to be shipped out next week if the drug receives emergency-use approval from the FDA. The company has pledged to deliver some 20 million doses by April and 100 million by late June.

Approval may come as early as this weekend.


India's coronavirus cases mysteriously fell

The government committed to inoculating 300 million people by August this year, which was touted as the largest and fastest vaccination program in the world. But it has fallen behind schedule.

The initial phase targeted healthcare and frontline workers, such as police officers, sanitation staff and soldiers, and is about to be expanded to people aged over 60 and those over 45 with health problems.

But daily injections have varied wildly between 17,000 and 650,000, which is far below the 1.5 million per day it needed to reach its goal on time.

By comparison, the United States is averaging 1.2 million vaccinations a day.

Hospitals in India were pushed to the brink last year as the country recorded close to 100,000 cases a day.

The number of daily cases has since come tumbling down to almost a tenth of the September peak, but a fresh surge has prompted restrictions to be reimposed in several states, particularly in Maharashtra and Kerala.

Delhi's mysterious drop in cases: The nation's capital, Delhi, is recording fewer than 150 cases of COVID-19 a day, far below its peak of more than 8,000 in November 2020. The city recently recorded three days of zero COVID-19 deaths, a feat not witnessed since the early months of the pandemic.

Many coronavirus wards in the capital have been shut down and converted back to normal operations. India's largest coronavirus treatment hospital, Lok Nayak Hospital, had its entire 2,500-bed capacity dedicated to treating coronavirus patients. Now, it has 300 coronavirus beds and around 30 patients.

"We were full. There was a time when a lot of deaths were occurring here," Dr Sandeep Garg said, who now manages a non-COVID ward. "Yesterday, we had seven to 10 patients."

Some health experts believe the rate of infection has dropped so significantly because the real rate of infection was so great, and the virus is now struggling to spread widely.

A recent serological survey, which tested 28,000 residents across Delhi, found more than half of the test subjects had developed antibodies, more than 60 per cent in some regions, meaning they had previously been infected with the virus.

This would put Delhi's actual rate of infection 30 times higher than the official data. The state's health minister said the city was "inching" towards herd immunity.

The exact threshold for herd immunity against COVID-19 is unknown, but some experts believe about 70 to 90 per cent of a population would need to have antibodies to stop the virus in its tracks.

A nationwide serological survey suggested a quarter of the Indian population had developed antibodies, which would not be enough to achieve herd immunity.

"Pandemics by their very nature are diseases of the crowd," said Dr Sumit Ray, who runs the not-for-profit Holy Family Hospital in Delhi. "The [serological] surveys show it has infected so many people that it is finding it difficult to transmit itself."

Health experts have warned against people letting their guard down, as the rate of mask wearing and social distancing drop significantly.

"Will a mutation happen which will change that? We don't know yet," Dr Ray said. "Will the herd immunity, the antibodies, last for how long? We don't know."

Suspicion could be a barrier to a swift vaccine rollout
India has approved two locally made vaccinations, the Oxford-AstraZeneca vaccine, known locally as Covishield, as well as Covaxin, which was developed by Indian pharmaceutical giant Bharat Biotech.

It is also considering approving the Russian Sputnik 5 vaccine. Pfizer withdrew its application for emergency approval after the government requested more data.

Covaxin was approved despite still not completing its final trials. Bharat Biotech is expected to publish its phase 3 data sometime in March.

The Indian Government has maintained earlier trials showed Covaxin is safe and effective. While the Indian Council for Medical Research said the urgent approval was necessary given the pandemic.

The vaccine is being widely used in the district of Barmer, near the Pakistan border, a region so remote that camels are needed to deliver the drug to remote villages. Bhika Ram has managed the region's vaccine depot for 35 years and has received two injections. "I have a strong feeling that I have acquired immunity," he said. "I am safe, and others are also safe from me."


‘Trump was right’: Conservatives double down on ex-president

Orlando, Florida: Even before you step inside the Conservative Political Action Conference, America’s largest annual gathering of right-wing activists, it’s clear who commands the hearts and minds of today’s Republican Party base.

A cigarette-smoking man wearing a red “Bikers for Trump” hat is circling the conference venue on an oversized tricycle. His bike is emblazoned with a sign that reads: “Trump was right about everything.” A woman, wrapped in an American flag, waves a giant flag that says: “F--- Biden and f--- you for voting for him.”

Inside four-star Hyatt hotel that is hosting the conference, the adoration for the former president is even more intense. The must-see attraction at this year’s event is a giant, glistening gold statue of Trump wearing thongs on his feet and holding a wand.

On Monday (AEDT) the conference-goers will be able to see Trump himself, when the three-day event culminates in Trump’s first speech since leaving the White House.

The artist who made the statue, Tommy Zegan, explains that it is taking a jab at former president Barack Obama, who once said of Trump’s promise to bring manufacturing jobs back to the United States: “What magic wand do you have?”

This year’s conference is taking place just over a month since Trump left the White House and Democrats took control of the US Senate. But it is accompanied by none of the soul-searching and internecine debates you might expect following such significant defeats.

That’s because many of those attending the event do not believe Trump lost the election – because of voter fraud.

In order to return to political dominance, so the thinking goes, Republicans don’t need a new candidate or to adjust their policy agenda: they must simply find a way to stop their opponents from cheating next time.

“It was rigged,” Zegan says of the November election. “There were too many anomalies.”

If Trump were to run again in 2024, Zegan says, he would definitely support him.

Anna Villalobos, who is running a stall at the conference selling MAGA (Make America Great Again) hammocks, says: “The numbers don’t add up. How could 80 million people vote for Biden but only 20 million follow him on Twitter? I 100 per cent believe they stole the election.”

Ronald Solomon, who runs the MAGA Mall, which sells pro-Trump paraphernalia, says he is already doing a roaring trade in “Trump 2024” flags and caps.

“If Trump wants the nomination, he gets it,” Solomon says.

It’s the same story on the main stage, where speaker after speaker offers the same formula for returning to power: doubling down on Trumpism.

“Let me tell you this right now: Donald J. Trump ain’t going anywhere,” Texas senator Ted Cruz tells the crowd to loud applause. “These deplorables are here to stay.”

Florida senator Rick Scott says abandoning Trump’s policies on trade, immigration and China would be like reverting to antiquated technology such as flip-phones or typewriters.

“We will not win the future by trying to go back to where the Republican Party used to be,” he says. “If we do, we will lose the working base that President Trump so animated. We’re going to lose elections across the county and, ultimately, we’re going to lose our nation.”

Democrats in Washington, Scott says, “are trying to turn this country into a communist ash heap”.

Florida congressman Matt Gaetz says: “We proudly represent the pro-Trump America First wing of the conservative movement. We’re not really a wing, we’re the whole body.”

Gaetz jokes that if Liz Cheney, the Wyoming congresswoman who voted to impeach Trump last month, had been at the conference she would have been booed off stage.

“What does that say?” he asks. “The leadership of our party is not found in Washington, D.C.”

As would be expected at such an event, there are panel sessions on abortion, gun ownership and foreign policy.

Big tech bias against conservatives is a major focus, with several speakers advocating breaking up social media giants such as Facebook and Google. It’s an interventionist position that until recently would have been well oustide the conservative mainstream.

But, by far, the dominant theme at this year’s conference is election integrity.

Seven panel sessions in total are dedicated to “protecting elections”, with speakers proposing a series of new measures to tighten voting rules.

“Democrats, not Republicans, installed ballot drop boxes on sidewalks, where nobody oversaw them,” conservative commentator Deroy Murdock says. “How many fraudulent ballots got deposited in these boxes unchecked and then got counted? Who knows.”

T.W Shannon, a former state legislator from Oklahoma, appears to justify the deadly January 6 assault on Congress by saying: “The reason that people stormed the Capitol was because they felt hopeless because of a rigged election.”

Donald Trump junior, himself seen as a possible future Republican presidential candidate, delights the crowd by using air quotes when referring to Joe Biden’s “80 million votes” and joking that the event should be renamed TPAC: the Trump Political Action Conference.

Offering a preview of his father’s upcoming address, he says: “I imagine it will not be what we call a ‘low-energy’ speech. And I assure you that it will solidify Donald Trump and all of your feelings about the MAGA movement as the future of the Republican Party.”




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