Many questions.
In interviews with CNN, several vaccine advisers to the U.S. government have left no doubt as to whether AstraZeneca’s vaccine would eventually receive FDA approval. However, they said the company’s application was likely to pose problems that did not arise when the three Covid-19 vaccines currently in use in the United States – made by Pfizer, Moderna and Johnson & Johnson – for them own considered. authorizations for emergency use.
“It is clear that more questions have been raised about the AstraZeneca vaccine than about any other vaccines currently allowed in the US,” said Dr. Arnold Monto, acting chairman of the FDA’s advisory committee on vaccines and related biological products, said. apply and the FDA advises whether it should be approved.
The advisers – who work at academic medical centers and not for the government – said that the reports of blood clots after vaccination, which caused more than a dozen Western European countries to suspend the use of the AstraZeneca vaccine, did not the only problem is not. Questions were also asked about other aspects of AstraZeneca’s efficacy and safety data.
“It does feel different, and it feels different, even if it is the whole blood clot formation,” said Dr. William Schaffner, a liaison member of the CDC’s Advisory Committee on Immunization Practices, said.
Monto, Schaffner, and other government advisers said they were looking forward to receiving the “dossier” of data on the safety and efficacy of a vaccine that the FDA is publicly announcing as a pharmaceutical company applying for emergency use.
“I will bring an open mind to this deliberation,” said Dr. Ofer Levy, a member of the FDA’s vaccine advisory committee, said.
“I’ll go where the data leads me,” says another member, Dr. H. Cody Meissner.
As more and more European countries have lifted their AstraZeneca vaccination, the company as well as international health agencies have defended the vaccine.
“Everyone’s safety is our top priority,” AstraZeneca was quoted as saying by CNN on Wednesday. “About 17 million people in the EU and the UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population.”
Despite this support, several U.S. government advisers have said they are concerned that many Americans may experience it after months of hearing questions about the AstraZeneca vaccination, and that they will not want to take it.
“It is difficult to unravel the clock,” said Dr. Paul Offit, a member of the FDA advisory committee, said. “Once people are scared, it’s hard to scare them off.”
New report on blood clots
According to an EMA statement issued on Thursday, ‘the [AstraZeneca] vaccine is not associated with an increase in the overall risk of blood clots. ‘
The statement said that around 20 million people in the UK and the European Union, as well as Iceland, Liechtenstein and Norway, had received the AstraZeneca vaccine since March 16, and that there were specific types of rare clotting problems associated with low platelets.
The number of reports of the rare clotting problems “exceeds the expected, and causality, although not confirmed, can therefore not be ruled out”, according to the statement, which indicates that the labeling on the vaccine will be updated to provide more information on to include these events.
One type of clot is mesenteric venous thrombosis, which is a clot in one or more of the major arteries that draws blood from the intestines. Another is cerebral venous sinus thrombosis, where a clot forms in the drainage system of the brain. A third is distributed intravascular coagulation, which is blood clots in multiple blood vessels.
The EMA said it had reviewed seven cases of disseminated intravascular coagulation and 18 cases of cerebral venous sinus thrombosis as of March 16.
‘One problem after another’
The AstraZeneca vaccine, developed in partnership with the University of Oxford, started with the reputation of being one of the world’s most promising Covid-19 vaccines.
Dr Adrian Hill, one of Oxford’s leading scientists, has sometimes even insulted other vaccine makers, calling Modern’a Covid-19 vaccine technology ‘strange’ and ‘unproven’.
Menelas Pangalos, executive vice president for biopharmaceutical research and development at AstraZeneca, told the Wall Street Journal in November that “the bug was actually irrelevant” and that the vaccine “reaches the approval threshold with a vaccine that is more if 60% is effective. ”
Currently, more than a dozen European countries have suspended the use of the vaccine due to concerns about blood clots.
“It’s so ironic – last summer there were usually quite reluctant British clovers who beat their own drums – ‘We’re going to be first, we’re going to be the best’ – and it’s the vaccine that has had one problem after another, Schaffner said.
A AstraZeneca spokesman pointed out to CNN the Lancet study published in January and found that the vaccine ‘has an acceptable safety profile and is effective against symptomatic COVID-19’.
“It is much lower than would be expected to occur naturally in a general population of this size,” according to the company statement, adding that there is “no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, group or in any particular country. ”
The news release did not mention the rare types of clotting events that European regulators discussed on Thursday.
Agreements for 300 million AstraZeneca doses
While government advisers have said that more vaccine is better, they say it is unclear what role AstraZeneca’s doses will play if the vaccine is granted.
The government advisers with whom CNN spoke said if the AstraZeneca vaccine is distributed in the US, they are worried that Americans may perceive it as inferior to the three already being distributed.
“I’m very worried that there will be a lot of people who would say a lot of thanks to AstraZeneca for all this publicity,” said Schaffner, the CDC adviser.
The Biden administration has already planned to ship several million doses of AstraZeneca to other countries.
“We can be Solomon-like and cut the baby in half and say we’ve contracted to buy these doses, and we’ll use a third of them and give the rest away to developing countries and do some vaccination diplomacy,” he said. Schaffner said. “It’s a possibility.”
CNN’s Ryan Prior, Samira Said, Michael Nedelman and Casey Hicks contributed to this report.