FDA, CDC advisers say they expect many questions about the AstraZeneca Covid-19 vaccine

FDA, CDC advisers say they expect many questions about the AstraZeneca Covid-19 vaccine

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Many questions.

In interviews with CNN, several vaccine consultants from the U.S. government did not doubt whether the AstraZeneca vaccine would eventually obtain authorization for emergency use from the FDA. They said, however, that the company’s order is likely to bring problems that did not arise when the three Covid-19 vaccines currently used in the United States – made by Pfizer, Moderna and Johnson & Johnson – were considered on their own to authorize emergency use. .

“It is clear that more questions have been raised about the AstraZeneca vaccine than about any of the other vaccines that are now authorized in the United States,” said Dr. Arnold Monto, acting chairman of the FDA Vaccine and Related Biological Products Advisory Committee, which analyzes the vaccine applications and informs the FDA about whether they should be authorized.

These advisers – who work in academic medical centers and not for the government – said reports of blood clots after vaccination, which caused more than a dozen Western European countries to stop using the AstraZeneca vaccine, are not the only one problem. Questions were also raised about other aspects of AstraZeneca’s efficacy and safety data.

“The sensation is different, and it looked different even before the whole blood clot,” said Dr. William Schaffner, a liaison member of the CDC’s Immunization Practices Advisory Committee.

AstraZeneca hopes to ask the FDA to authorize its Covid-19 vaccine for emergency use in March or early April, sources with knowledge of the company’s ongoing clinical trial told Reuters last week.

Monto, Schaffner and other government advisers said they hope to receive the “dossier” of data on the safety and efficacy of a vaccine that the FDA publishes publicly when a pharmaceutical company applies for emergency use authorization.

“I will bring an open mind to these deliberations,” said Dr. Ofer Levy, a member of the FDA’s vaccine advisory committee.

“I will go where the data takes me,” said another member, Dr. H. Cody Meissner.

As more and more European countries suspend the launch of the AstraZeneca vaccine, the company, as well as international health agencies, are advocating the vaccine.

“The safety of everyone is our first priority,” according to a statement from AstraZeneca sent to CNN on Wednesday. “About 17 million people in the EU and the UK have already received our vaccine, and the number of blood clot cases reported in this group is less than the hundreds of cases that would be expected among the general population.”

The World Health Organization, the UK health authorities and the European Medicines Agency have expressed their support for the AstraZeneca vaccine, saying its benefits outweigh any risks.

Despite this support, several advisers to the United States government said they fear that after months of hearing about issues related to the AstraZeneca vaccine, many Americans may find it problematic and not want to take it.

“It is difficult to undo that bell,” said Dr. Paul Offit, a member of the FDA’s advisory committee. “Once people are scared, it is difficult to stop taking care of them.”

New blood clot report

According to an EMA statement released Thursday, “the [AstraZeneca] the vaccine is not associated with an increased overall risk of blood clots. ”

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The statement noted that some 20 million people in the UK and the European Union, as well as in Iceland, Liechtenstein and Norway, received the AstraZeneca vaccine on 16 March, and there have been reports of some specific types of rare coagulation problems associated low blood platelets.

The number of reports of these rare clotting problems “exceeds expectations and causality, although unconfirmed, cannot be excluded,” according to the statement, which noted that the vaccine label will be updated to include more information about these events.

One type of clot is mesenteric venous thrombosis, which is a clot in one or more of the main veins that drain blood from the intestines. Another is cerebral venous sinus thrombosis, where a clot forms in the brain’s drainage system. A third is disseminated intravascular coagulation, which consists of blood clots in various blood vessels.

The EMA reported that, until March 16, it had reviewed seven cases of disseminated intravascular coagulation and 18 cases of cerebral venous sinus thrombosis.

‘One failure after another’

The AstraZeneca vaccine, developed in partnership with the University of Oxford, started with the reputation of being one of the most promising Covid-19 vaccines in the world.

South Africa stops launching AstraZeneca vaccine after study shows it offers less protection against the variant
In the spring and last summer, Oxford researchers considered her the winner, although at times they went back and warned against exaggerated promises.

Dr. Adrian Hill, one of Oxford’s leading scientists, sometimes even insulted other vaccine manufacturers, for example, calling the Modern’a Covid-19 vaccine technology “strange” and “unproven”.

But, a year later, AstraZeneca faces challenges. Twice, it suspended clinical trials when participants who received the vaccine became ill – both times it was restarted when it was determined that the diseases were unrelated to the vaccine.
Then, in November, doubts arose about the company’s effectiveness data and it was revealed that a mistake was made in the trial and some participants received the wrong dose. Oxford told CNN at the time that a “difference in the manufacturing process” had led to the error.
“I have done a lot of clinical trials with vaccines in the past few decades and that has never happened,” said Meissner, a member of the FDA’s vaccine advisory committee. “I read in their Lancet newspaper how they explained it, but it was a little bit devious.”

Menelas Pangalos, executive vice president of biopharmaceutical R&D at AstraZeneca, told the Wall Street Journal in November that “the error was really irrelevant” and that the vaccine “meets the threshold for approval with a vaccine more than 60% effective” .

Then, last month, South Africa paused its launch of the AstraZeneca vaccine after a study showed it offered less protection against the coronavirus variant that was first identified there. That study, published later in the New England Journal of Medicine, found that the AstraZeneca vaccine “showed no protection from mild to moderate Covid-19” due to the variant.
Biden administration finalizing plans to send millions of doses of AstraZeneca vaccine to Canada and Mexico

Currently, more than a dozen European countries have suspended the use of the vaccine due to concerns about blood clots.

“It is so ironic – last summer there were these British gifts generally very reticent hitting their own drums – ‘Let’s be the first, let’s be the best’ – and this is the vaccine that has failed one after another,” said Schaffner.

An AstraZeneca spokesman pointed to CNN for the Lancet study published in January that found that the vaccine had “an acceptable safety profile and was found to be effective against symptomatic COVID-19.”

A press release from AstraZeneca on Sunday said that of 17 million people who received their vaccine in the European Union and the UK, there were 15 events of deep vein thrombosis and 22 events of pulmonary embolism, based on information that the company had received on March 8

“This is much less than would be expected to occur naturally in a general population of this size,” according to the company statement, which added that there was “no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, sex, batch or in any particular country. ”

The press release did not mention the rare types of coagulation events discussed by European regulators on Thursday.

Agreements for 300 million doses of AstraZeneca

AstraZeneca already has agreements with the United States government to deliver 300 million doses, according to statements prepared by the company last month to Congress.

Although government advisers say more vaccine is better, they say it is unclear what the role of AstraZeneca doses is if their vaccine is authorized.

There will be more than enough vaccine from Pfizer, Moderna and Johnson & Johnson to vaccinate all American adults by the end of May, said Covid White House coordinator Jeff Zients earlier this month.

The government advisers with whom CNN spoke said that if the AstraZeneca vaccine is distributed in the United States, they fear that Americans may consider it to be less than the three that are already being distributed.

“I am really concerned that many people will say ‘thank you, but not’ to AstraZeneca because of all this publicity,” said Schaffner, the CDC consultant.

He said that if there is not enough demand for this, the United States could donate part of its supply of AstraZeneca to developing countries, where it would be particularly useful because it is easier to transport and store than vaccines from Pfizer or Moderna.

The Biden government has already announced plans to send a few million doses of AstraZeneca to other countries.

“I can confirm that we have 7 million releasable doses of AstraZeneca,” White House press secretary Jen Psaki told the White House press conference on Thursday. “2.5 million of them, we are working to finalize plans to lend to Mexico and 1.5 million to Canada.”

“We could be like Solomon and cut the baby in half and say that we contracted the purchase of these doses, and we will use a third of them and donate the rest to developing countries and do a little vaccination diplomacy,” Schaffner said. “This is a possibility.”

CNN’s Ryan Prior, Samira Said, Michael Nedelman and Casey Hicks contributed to this report.

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