Government vaccination advisers say they do not anticipate the use of AstraZeneca in the US

Government vaccination advisers say they do not anticipate the use of AstraZeneca in the US

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But questions have arisen about the accuracy of AstraZeneca’s data, and even more significant: European drug regulators said on Wednesday there was a possible link between the AstraZeneca vaccine and rare blood clots. Some countries – more than 70 have approved the shot – have now restricted its use.
Dr. Anthony Fauci told CNN on Wednesday that even if the U.S. Food and Drug Administration grants emergency use of AstraZeneca’s vaccine, it is currently not required in the United States.

‘We have already contracted enough vaccines, from Moderna and from Pfizer and from [Johnson &Johnson], “he said.” There are no plans to start using the AstraZeneca immediately [vaccine] even if it is approved by the EUA, which it could very well do. ‘

Fauci said it was not because of the AstraZeneca vaccine itself, but that it is not needed in the US right now.

“This is not a charge against the product. We just have a lot of vaccinations,” he said.

The EU agency finds that the vaccination of AstraZeneca can cause rare blood clots, as the UK recommends other shots for under 30s

But experts advising the government on vaccine policy say it does not paint the whole picture.

The three advisers spoke to CNN about the condition of anonymity due to the sensitivity surrounding AstraZeneca’s possible application to the FDA.

One adviser told CNN that federal health officials have expressed concern about the fact that the presentation of AstraZeneca could increase the hesitation of vaccines in the US, which is already a problem among some groups.

“I think they are crossing their fingers that AstraZeneca will not apply for permission for emergency use,” the adviser said. ‘This vaccine has a checkered past. There is luggage. Why the road down if we do not have to? ‘

Pfizer, Moderna and Johnson & Johnson’s vaccinations have excellent safety records, with tens of millions of shots without any serious side effects.

Everyone would ask questions, ‘You’re not giving me that new blood clot vaccine, are you? ‘”, Said another adviser, referring to the AstraZeneca vaccination.” Why mud the water with a vaccine that has a somewhat checkered reputation? “

AstraZeneca’s answer

In an email, an AstraZeneca spokesman declined to comment on Fauci’s statements or the advisers’ concerns, but pointed out to CNN AstraZeneca’s Phase 3 results in the US trial, which show the vaccine is 76% effective was to prevent symptomatic Covid-19 and 100%. effective in preventing serious or critical illness and hospitalization.
The AstraZeneca vaccine is extremely cheap and easier to store and transport than the Pfizer and Moderna vaccines, making it particularly useful in developing countries.

The spokesperson wrote that the company is committed to a fair and equitable access to vaccines to communities around the world, regardless of geography or income level ‘and is’ very proud of the progress made so far’ by the company and its global partners .

AstraZeneca Covid-19 Vaccine: How common are blood clots and should I be concerned?
On Wednesday, AstraZeneca issued a statement in response to findings by the European Medicines Agency and the UK’s Regulatory Agency for Medicines and Healthcare.

“Today, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and European Medicines Agency (EMA) completed their assessment of extremely rare low-platelet coagulation events of more than 34 million people vaccinated with AstraZeneca’s COVID-19 vaccine in the United Kingdom and the EU, “according to the statement. “[The agencies] came to the conclusion that these events have a possible connection with the vaccine and requested that it be listed as an extremely rare side effect. Overall, both of these reviews confirmed that the vaccine offers a high level of protection against all seriousness of COVID-19 and that these benefits still outweigh the risks. “

The statement also states that the World Health Organization has found that it is a causal link [between the vaccines and blood clotting events] is considered acceptable but is not confirmed. ‘

Advisors say they will not take the AstraZeneca vaccine

CNN spoke to three state intelligence advisers who said they would not take the AstraZeneca shot if they took the vaccination that Pfizer, Moderna or Johnson & Johnson made.

“Everyone keeps you out of the hospital and prevents you from dying, but the three have a better safety profile,” said one of the advisers.

But they also said they would take the AstraZeneca vaccine if it was the only one available to them.

US government removes AstraZeneca from infected vaccine

One of the advisers recalled that she had received an email from an acquaintance in Germany asking if she should get the AstraZeneca vaccine, which was the only one available to her.

“I told her absolutely yes,” the adviser said.

A ‘Delicate’ Place for the FDA

The AstraZeneca spokesman told CNN the company is currently submitting to the FDA for authorization for emergency use.

This could put the FDA in a difficult position.

An inch from the FDA – for whatever reason – would be problematic for two reasons.

First, the FDA is considered the gold standard around the world, and disapproval can cast doubt on a vaccine used by dozens of countries that has been given to nearly 200 million people.
Second, if the FDA does not authorize the vaccine for AstraZeneca, it could make the US uncomfortable donating its shots – it has agreements to buy 300 million doses – to countries with a vaccine shortage.

“It will look like we are dumping our second-rate vaccine: ‘We do not want to use it, but they can use it in Mali. “It will look awful,” said one of the advisers. “It’s definitely a delicate situation.”

An alternative would be to approve the AstraZeneca vaccine, explain that the US does not need it, and then donate US supplies to countries with a vaccine shortage.

But still, other countries may still consider it an inferior vaccine, the advisers said.

AstraZeneca’s spokesperson did not provide a timeline for the application to the FDA. On March 22, Ruud Dobber, president of AstraZeneca’s bio-pharmaceutical business unit, told CNBC that the company plans to apply for an EUA in the first half of April.

Some of the advisers told CNN they hope executives change their minds.

“If I were the CEO of AstraZeneca, I could say, ‘What’s the point of going to the FDA? If we are approved, our vaccine will not be used [in the US], and it will be demonstrated in the press, and our reputation will disappear, ” the adviser said.

If they do not apply, the adviser says, the company could ‘save face and still promote its vaccine around the world’.

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