The federal government’s vaccine advisors told that they would not foresee that AstraZeneca’s coronavirus vaccine will be used in the United States. Even if this vaccine is provided, they personally do not want to use it, given the other available options.
On the other hand, people have high hopes for AstraZeneca’s vaccine, and the United States has pledged to invest up to $1.2 billion in the vaccine.
However, questions about the accuracy of AstraZeneca’s data have raised questions. More importantly, on Wednesday, the European drug regulatory agency stated that there may be a link between the AstraZeneca vaccine and rare blood clots. Some countries/regions (more than 70 countries/regions that have authorized the use of the vaccine shot) now restrict its use.
On Wednesday, Dr. Anthony Fauci stated that even if the US Food and Drug Administration grants emergency use of the AstraZeneca vaccine, the US does not need the vaccine now.
He said: We have signed enough vaccine contracts with Moderna and Pfizer and [Johnson & Johnson]. Even though it gets the EUA approval, there is no plan to start using the AstraZeneca vaccine immediately. This is likely to happen.
Fauci said that this is not because of the AstraZeneca vaccine itself, but it is not necessary for the United States now. He said: This is not an indictment against the commodity. We just have a lot of vaccines.
But experts who advise the government on vaccine policy say this does not tell the whole story. The three consultants spoke on the conditions of anonymity because of the sensitivity surrounding AstraZeneca’s possible application to the FDA.
One advisor told that federal health officials have privately expressed concern that providing AstraZeneca vaccines in the United States may increase vaccine hesitation, which is already a problem in certain populations.
The advisor said: I think they are accusing AstraZeneca of not applying for emergency use authorization. This vaccine passes very late and has a checkered past. There is baggage. If we don’t have to go down that road, why should we go that way?
Vaccines of Pfizer, Moderna, and Johnson & Johnson have excellent safety records and can be injected tens of millions of times without any serious side effects.
Another advisor said about AstraZeneca’s vaccines that everyone will ask questions-‘Are not you giving me this new blood coagulation vaccine? Why muddy the waters with a vaccine shot that comes with a somewhat outrageous reputation?
In an email, an AstraZeneca spokesperson declined to respond specifically to advisors’ concerns or Fauci’s statement, but we pointed out that AstraZeneca’s Phase 3 trial results in its U.S. trial indicated that the vaccine is 76% effective in preventing symptomatic coronavirus, and 100% effective in preventing critical or severe illness and hospitalization.
Compared with Pfizer and Moderna’s vaccines, AstraZeneca’s vaccines are particularly cheap and easy to store and transport, which makes them particularly useful in developing countries.
The spokesperson wrote that the company is committed to ensuring that fair and just vaccines are available to communities all over the world, regardless of location or income level, and it is very proud of the progress the company, its global partners and organization have made so far.
On Wednesday, AstraZeneca issued a statement in response to the findings of the European Medicines Agency and the UK Drugs and Healthcare Products Regulatory Agency.
Today, the British MHRA (Medicines and Healthcare Products Regulatory Agency) and the EMA (European Medicines Agency) have completed the very low platelet vaccination of 34 million people who have received the AstraZeneca coronavirus vaccine in the United Kingdom and the European Union, according to the statement.
The agencies believe that these events may be related to the vaccine and requested that they be listed as extremely rare potential side effects. In general, these two reviews reiterated that the vaccine can provide a high level of protection for everyone against all the COVID-19 illness-, and these benefits still far outweigh the risks.
The statement also said that the World Health Organization found that the causal relationship between the vaccine and the blood coagulation event is considered reasonable, but it has not been confirmed.
Advisors said they would not take the AstraZeneca vaccine
The source talked to three government vaccine advisors. They said that if they could choose to take vaccines produced by Pfizer, Modena, Johnson & Johnson, or AstraZeneca then they would not take the AstraZeneca vaccine.
One of the advisors said: They all let you leave the hospital and keep you from dying, but the safety of the three is higher.
But they also said that if this is the only vaccine they can use, they will take AstraZeneca’s vaccine.
One of the advisors remembered receiving an email from an acquaintance in Germany asking if she should be vaccinated with AstraZeneca, which was the only vaccine she could use. The advisor said: I absolutely told her yes.
A “Subtle” Part of the FDA
A spokesperson of AstraZeneca told that the company is currently submitting an emergency use authorization form to the FDA. This may put the FDA in a dilemma.
Regardless of the reason, the FDA will speak out for two reasons. First, the FDA is considered to be the gold standard worldwide. Failure to be approved may cast doubt on the vaccine that dozens of countries rely on. The vaccine has been provided to nearly 200 million people.
Secondly, if the FDA does not approve AstraZeneca’s vaccine, it may embarrassingly donate US injection vaccines to countries with vaccine shortages (it has agreed to purchase 300 million doses).
It seems that we are abandoning the second-rate vaccine-We don’t want to use it, but they can use it in Mali. One of the advisors said that this looks terrible. This must be a delicate situation for sure.
Another option is to approve the AstraZeneca vaccine, explain that the United States does not need it, and then donate US supplies to countries where the vaccine is in short supply.
The advisors said, but even so, other countries may still see it as dumping low-quality vaccines.
The spokesperson of AstraZeneca did not provide a timeline for applying to the FDA. The president of AstraZeneca’s biopharmaceutical business unit, Ruud Dobber told CNBC on March 22 that the company plans to apply for a EUA in the first half of April.
Some advisors told that they want company executives to change their minds.
The Advisor said: If I were the CEO of AstraZeneca, I might say, What is the purpose of going to the FDA? If approved, our vaccine will not be used in the US. This will be confirmed in the press and our reputation will be tarnished.
The advisor said that if it does not apply, the company can ‘maintain face and still promote its vaccine globally’. If they don’t apply, the adviser said, the company could “save face and still promote its vaccine around the world.”