AstraZeneca may pursue a full license to distribute its COVID vaccine and skip emergency-use authorization - further delaying rollout of its shots by months

 AstraZeneca may skip asking the U.S. Food and Drug Administration for emergency-use authorization for its COVID-19 vaccine and instead pursue the more time-intensive application for a full-fledged license to sell the shot.

The move would further delay any rollout of the British drugmaker's shots in the United States by a month or two, sources told the Wall Street Journal on Friday.

A major motivation to skip the emergency-use authorization is that the United States has already ordered so many doses of FDA-approved shots from Pfizer, Johnson & Johnson, and Moderna for use domestically, the outlet reported. 


The FDA has required AstraZeneca, whose vaccine has been widely given in more than 100 countries worldwide, to provide data from the vaccine's use in other countries as well as its data from human clinical trials, the outlet reported. 

AstraZeneca may skip asking the U.S. Food and Drug Administration for emergency-use authorization for its COVID-19 vaccine

AstraZeneca may skip asking the U.S. Food and Drug Administration for emergency-use authorization for its COVID-19 vaccine

The move would further delay any rollout of the British drugmaker's shots in the United States by a month or two, sources told the Wall Street Journal

The move would further delay any rollout of the British drugmaker's shots in the United States by a month or two, sources told the Wall Street Journal

A source told the Wall Street Journal that the government has to approve of skipping the emergency-use application to apply for full approval

A source told the Wall Street Journal that the government has to approve of skipping the emergency-use application to apply for full approval

A health worker prepares a dose of the AstraZeneca/Oxford COVID-19 vaccine at a temporary vaccine center set up in northeast England on Friday

A health worker prepares a dose of the AstraZeneca/Oxford COVID-19 vaccine at a temporary vaccine center set up in northeast England on Friday

AstraZeneca said last week that it was working as fast as possible to compile data on its COVID-19 vaccine to apply for emergency approval, but that the dataset was very big because of the number of people who have received the jab.


The company had said it planned to apply for U.S. approval in the coming weeks.

The Moderna, Pfizer and Johnson & Johnson shots were not yet used widely when they received emergency use authorization.

The federal government helped fund the testing and development of AstraZeneca’s vaccine in the United States.

A source told the Wall Street Journal that the government has to approve of skipping the emergency-use application to apply for full approval. 

Last week, an AstraZeneca executive said the company could skip the emergency-use filing if officials told it to instead apply for full approval, the outlet reported. 

A chart shows the percentage of vaccinated people around the US

A chart shows the percentage of vaccinated people around the US


The White House said late in April that the United States would start to share up to 60 million doses of AstraZeneca's coronavirus vaccine with other countries over the next few weeks.

AstraZeneca's COVID-19 shot, developed by Oxford University, has resulted in reports of rare blood clots with low platelet levels that occur more commonly in younger adults. Some countries have advised the shot be given only to older people.

The company did not immediately respond to a request for comment late on Friday. 

 Meanwhile, a recent study found that the risk of blood clots after the Oxford jab is ‘small’ with people three times more likely to die if they have not had the vaccine, a study has found.

Researchers in Denmark and Norway looked at the nationwide rates of blood clots and related conditions in 280,000 people who had had the jab between February and March this year.

They found slightly increased rates of vein blood clots including clots in the veins of the brain, compared with expected rates in the general population.

However, the researchers stress that the risk of such adverse events was low while those who were unvaccinated were almost three times more likely to die than those who had it.

 Dr. Anthony Fauci said last month that the US may not even need AstraZeneca's COVID-19 vaccine.    

Dr. Fauci says AstraZeneca to release accurate statement on vaccine
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Fauci, director of the National Institute of Allergy and Infectious Diseases and chief medical adviser to the White House, told Reuters that America has enough contracts with other vaccine makers to inoculate its entire population even without approving the AstraZeneca vaccine.

The US has so far authorized and rolled out three COVID-19 vaccines - Pfizer and Moderna with their two-shot vaccines and Johnson & Johnson's one-shot vaccine. 

Fauci said the supply coming from these three drugmakers will not only be enough to get all Americans vaccinated but may also be enough for booster shots to be given out in the fall. 

'My general feeling is that given the contractual relationships that we have with a number of companies, that we have enough vaccine to fulfill all of our needs without invoking AstraZeneca,' Fauci said. 

'If you look at the numbers [of doses] that we're going to be getting, the amount that you can get from J&J, from Novavax from Moderna if we contract for more, it is likely that we can handle any boost that we need, but I can't say definitely for sure.' 

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