Saturday, March 13, 2021

Halting AstraZeneca coronavirus vaccine rollout in EU an 'overreaction', according to experts

European authorities pausing the rollout of the AstraZeneca vaccine after a small number of people developed blood clots is an "overreaction", according to one leading Australian scientist.

More than 11 million people have been vaccinated with the AstraZeneca drug in the UK without evidence of an increase in blood clots

"You can't ignore these events, but I think it's an overreaction," Peter Collignon, an infectious diseases expert from ANU, said.

He said generally there were around 100 cases per 100,000 of blood clots in the general population and that the rate of blood clots from people who had received the AstraZeneca vaccine did not appear to be higher than that.

Professor Collignon said in any mass vaccination program, some people were going to have health issues that were not necessarily a consequence of receiving the vaccine.

"So we are going to see everything from heart attacks, to strokes, to pulmonary embolism, and we need to keep an eye on it but generally, this doesn't seem to be above what you would expect given that millions of doses have been given out," he said.

Professor Collignon said there was no evidence of increased blood clots in the phase 3 trials of the AstraZeneca vaccine.

The European Medicines Agency (EMA) said the AstraZeneca vaccine's benefits continue to outweigh its risk.

"There is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine," the EMA said. "The vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing," it added.

The EMA said there had been 30 cases of clot-related events among the 5 million Europeans who have received the jab.

One person in Austria died from blood clots and another was hospitalised with a blockage in the lung after receiving doses from a particular batch of the AstraZeneca vaccine.

Denmark suspended the shots for two weeks after a 60-year-old woman, given an AstraZeneca shot from a batch used in Austria, formed a blood clot and died, health authorities said.

Some EU countries subsequently suspended this batch as a precautionary measure, while a full investigation by the EMA was ongoing.

Italy also suspended the use of AstraZeneca when two men died in Sicily, however, those shots were not from the Austrian batch.

Norway, Iceland, Estonia, Lithuania, Luxembourg and Latvia have also stopped inoculations with the vaccine while investigations continue.

RMIT vaccine expert Kylie Quinn said increased clotting had not come up as a potential issue in the UK rollout of the vaccine.

"Biologically, I don't know why there would be a link between clots and this specific vaccine," she said.

Professor Collignon said it was important to monitor the vaccine rollout for any serious side effects, to see if it was above what you would expect to see in the general population.

"Tens of millions of doses of [the AstraZeneca] vaccine have been given around the world, so if there is an association with blood clots, which is doubtful, it is a pretty rare side effect compared to the consequences of getting COVID-19 itself," he said.

Experts said any apparent cluster of side effects needed to be investigated, but it did not mean the cause was the vaccine itself.

Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said the sensible approach was to make sure the "benefit and risk balance is in favour of the vaccine".

"This is a super-cautious approach based on some isolated reports in Europe," he said. "The problem with spontaneous reports of suspected adverse reactions to a vaccine are the enormous difficulty of distinguishing a causal effect from a coincidence.

"This is especially true when we know that COVID-19 disease is very strongly associated with blood clotting and there have been hundreds if not many thousands of deaths caused by blood clotting as a result of COVID-19 disease.

"The first thing to do is to be absolutely certain that the clots did not have some other cause, including COVID-19."

Australia's Chief Medical Officer Paul Kelly said there was "no evidence" the AstraZeneca jab caused blood clots.

"The Australian government is aware of reports some European countries have suspended the use of the AstraZeneca vaccine due to some reports of blood clots in people who have been vaccinated," he said.

"Safety is our first priority and in a large vaccine rollout like this, we need to monitor carefully for any unusual events so we will find them.

"This does not mean that every event following a vaccination is caused by the vaccine.

"But we do take them seriously and investigate and that's what Denmark is currently doing."

Professor Kelly noted there had been more than 11 million people vaccinated in the UK without evidence of an increase in blood clots.

Prime Minister Scott Morrison said any overseas developments in vaccine rollouts were monitored by the Therapeutic Goods Administration (TGA).

"The batches we distribute here in Australia are tested here by the TGA and we have robust processes," he said.


Serious allergic reactions do occur with COVID vaccines

The journal article below. It was rare (2%) and nobody died of it but the immediate availability of healthcare was important


We prospectively studied Mass General Brigham (MGB) employees who received their first dose of an mRNA COVID-19 vaccine (12/16/2020-2/12/2021, with follow-up through 2/18/2021) (eMethods in the Supplement). For 3 days after vaccination, employees completed symptom surveys through a multipronged approach including email, text message, phone, and smartphone application links. Acute allergic reaction symptoms solicited included itching, rash, hives, swelling, and/or respiratory symptoms (eAppendix in the Supplement).

To identify anaphylaxis, allergists/immunologists reviewed the electronic health records of employees (1) reporting 2 or more allergy symptoms, (2) described as having an allergic reaction in MGB safety reports, (3) logged by the on-call MGB allergy/immunology team supporting employee vaccination, and (4) referred to MGB allergy/immunology. Episodes were scored using the Brighton Criteria2 and the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network (NIAID/FAAN) criteria.3 Confirmed anaphylaxis required meeting at least 1 of these 2 sets of criteria.

We described characteristics and outcomes of anaphylaxis cases. We calculated incidence rates and 95% CIs of self-reported acute allergic reactions and confirmed anaphylaxis, using vaccine administrations as the denominator. We compared frequencies using χ2 tests, considering a 2-sided P value of .05 statistically significant. Analyses were conducted in SAS version 9.4. This study was approved by the MGB Human Research Committee with a waiver of informed consent.


Of 64 900 employees who received their first dose of a COVID-19 vaccine, 25 929 (40%) received the Pfizer-BioNTech vaccine and 38 971 (60%) received the Moderna vaccine. At least 1 symptom survey was completed by 52 805 (81%).

Acute allergic reactions were reported by 1365 employees overall (2.10% [95% CI, 1.99%-2.22%]), more frequently with the Moderna vaccine compared with Pfizer-BioNTech (2.20% [95% CI, 2.06%-2.35%] vs 1.95% [95% CI, 1.79%-2.13%]; P = .03, Table 1). Anaphylaxis was confirmed in 16 employees (0.025% [95% CI, 0.014%-0.040%]): 7 cases from the Pfizer-BioNTech vaccine (0.027% [95% CI, 0.011%-0.056%]) and 9 cases from the Moderna vaccine (0.023% [95% CI, 0.011%-0.044%]) (P = .76).

Individuals with anaphylaxis were a mean (SD) age of 41 (13) years, and 15 (94%) were female (Table 2); 10 (63%) had a prior allergy history and 5 (31%) had an anaphylaxis history. Mean time to anaphylaxis onset was 17 minutes (SD, 28; range, 1-120). One patient was admitted to intensive care, 9 (56%) received intramuscular epinephrine, and all recovered. Three employees, with prior anaphylaxis history, did not seek care.


As the Insurrection Narrative Crumbles, Democrats Cling to it More Desperately Than Ever

Twice in the last six weeks, warnings were issued about imminent, grave threats to public safety posed by the same type of right-wing extremists who rioted at the Capitol on January 6. And both times, these warnings ushered in severe security measures only to prove utterly baseless.

First we had the hysteria over the violence we were told was likely to occur at numerous state capitols on Inauguration Day. “Law enforcement and state officials are on high alert for potentially violent protests in the lead-up to Inauguration Day, with some state capitols boarded up and others temporarily closed ahead of Wednesday's ceremony,” announced CNN. In an even scarier formulation, NPR intoned that “the FBI is warning of protests and potential violence in all 50 state capitals ahead of President-elect Joe Biden's inauguration.”

The resulting clampdowns were as extreme as the dire warnings. Washington, D.C. was militarized more than at any point since the 9/11 attack. The military was highly visible on the streets. And, described The Washington Post, “state capitols nationwide locked down, with windows boarded up, National Guard troops deployed and states of emergency preemptively declared as authorities braced for potential violence Sunday mimicking the Jan. 6 attack on the U.S. Capitol by a mob of pro-Trump rioters.” All of this, said the paper, “reflected the anxious state of the country ahead of planned demonstrations.”

But none of that happened — not even close. The Washington Post acknowledged three weeks later:

Despite warnings of violent plots around Inauguration Day, only a smattering of right-wing protesters appeared at the nation’s statehouses. In Tallahassee, just five armed men wearing the garb of the boogaloo movement — a loose collection of anti-government groups that say the country is heading for civil war — showed up. Police and National Guard personnel mostly ignored them.

All over the country it was the same story. “But at the moment that Biden was taking the oath of office in Washington, the total number of protesters on the Capitol grounds in Topeka stood at five — two men supporting Trump and two men and a boy ridin’ with Biden,” reported The Wichita Eagle (“With Kansas Capitol in lockdown mode, Inauguration Day protest fizzles). “The protests fizzled out after not many people showed up,” reported the local Florida affiliate in Tallahassee. “The large security efforts dwarfed the protests that materialized by Wednesday evening,” said CNN, as “state capitols and other cities remained largely calm.”



CDC lets child migrant shelters fill to 100% despite COVID concern (Axios)

South Korea and the U.S. reach accord on troop cost sharing (Korea Herald)

New York lawmakers vote to strip Cuomo of pandemic emergency powers (Axios)

2021 sees a record number of bills targeting trans youth defending the dignity of girls and sports (Axios)

T-Mobile is forcing employees to complete a "White Privilege Checklist" (Not the Bee)

Biden to formally establish new Gender Policy Council (The Hill)

Democrats grease the budget wheels for writing off student debt by Biden decree (WSJ)

Twitter silent as Louis Farrakhan's misleading COVID vaccine claims go unchecked (Fox)

New York State Assembly Republicans launch impeachment effort against Governor Andrew Cuomo (NY Post)

Biden administration signals openness to adding "third gender" option for federal IDs (Examiner)

Policy: Time for Congress to reform civil asset forfeiture (National Review)

Free speech-suppressing Apple denies Parler's request to be reinstated in App Store (Post Millennial)

Mexican officials worried that Biden's immigration policy is incentivizing human smuggling and gang activity (Examiner)

Biden administration to resume undeserved taxpayer aid to Palestinians (Disrn)

Fewer than 1 in 5 support "defund the police" movement (USA Today)

In 70-30 vote, Senate confirms Merrick Garland as attorney general (CNBC)

In 66-34 vote, Senate confirms Michael Regan as EPA chief (Examiner)

Left-leaning poll shows 53-32 favor banning biological males from women's sports (Daily Wire)




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