The US Food and Drug Administration (FDA) is poised to fully approve the Pfizer coronavirus vaccine early next week as the Biden administration tries to persuade more Americans to get the shot.
Approval by the FDA will come on Monday or Tuesday, according to one official familiar with the plans, speaking on condition of anonymity ahead of the announcement. The Pfizer vaccine has been in use in the US based on an emergency use authorisation (EUA).
A vaccine manufacturer receiving full approval can introduce the vaccine into interstate commerce and market it for its approved uses for an indefinite length of time. An EUA is only in effect for the duration of the public health emergency.
An EUA is not a long-term alternative to full FDA approval. For this reason, manufacturers are encouraged by the FDA to continue conducting clinical trials to demonstrate the effectiveness of the vaccines and continue safety assessments to work toward full approval.
The lack of full approval by the FDA has been cited as a factor in the reluctance of some Americans to get the Covid vaccine. It has also emerged as a flashpoint in the debate over vaccine mandates passed by some states and cities. In San Francisco, for example, anyone wanting to dine inside a restaurant must provide proof that he or she has been fully vaccinated.
Typically, making vaccination a mandatory condition for participating in certain activities is only done after years of experience with a vaccine.
In any case, vaccinations in the US have been picking up, with slightly more than 1 million doses administered nationwide for the second consecutive day on Friday. More people are seeking out shots as case numbers and hospital admissions are rising rapidly once again because of the Delta variant surge.
New daily infections on Friday topped 145,000, compared with 12,000 at the end of June.
About half of the people getting shots on Friday, or 534,000, were newly vaccinated, said Cyrus Shahpar, the White House’s Covid-19 data director.
The latest figures show that 170 million people or 51.7% of the US population, are now fully vaccinated.
In India, meanwhile, authorities have granted emergency-use approval to the country’s first DNA-based vaccine as the government seeks to bolster its immunisation drive.
A three-dose vaccine developed by Ahmedabad-based Cadila Healthcare Ltd, which had reported 67% efficacy against symptomatic Covid in clinical trials in July, was given the go-ahead on Friday, the government said in a statement. It is the second locally developed shot to receive approval.
The vaccine, which Cadila claims works against newer virus strains including the Delta variant, adds to the country’s arsenal in fighting the virus.
