EXPLAINED | Pfizer Covid Vaccine Could Get FDA ‘Full Approval’ By Monday. Know What This Means

FDA recently set an unofficial deadline for full approval to Pfizer-BioNTech vaccine, saying it could come around Labor Day, i.e. Sept 6.

New Delhi: The US Food and Drug Administration (FDA) is likely to approve Pfizer-BioNTech’s two-dose Covid-19 vaccine on Monday, The New York Times has reported quoting “people familiar with the agency’s planning”.

While no official statement on this has come from the FDA yet, the NYT report said regulators were still working through a “substantial amount of paperwork and negotiation with the company”.   

The approval will expedite an earlier timeline decided to license the shot.

Quoting the sources familiar with the matter, the report said the approval might take more time if some components of the review are not completed before Monday.

FDA had recently set an unofficial deadline for the approval, saying it could come around Labor Day, which is September 6.

Once full approval is in, the drugmaker plans to ask the FDA to approve a third dose of the Covid vaccine as a booster shot, the report said. 

The Joe Biden administration has already announced that fully vaccinated adults should prepare to get booster shots eight months after their second doses, beginning September 20.

Pfizer has said a third shot is safe and effective against the infection, and it is likely to finish submitting data next week to substantiate its claim.

The regulators are still reviewing the application for full approval for Moderna’s vaccine. Moderna is planning to submit its data in support of a booster shot in September.

The Pfizer vaccine is not in use in India yet. According to reports, the Narendra Modi government is not inclined to give indemnity to Pfizer or any other foreign drug manufacturers against liabilities if recipients of their vaccines develop severe adverse reactions.

Earlier this year, Pfizer withdrew its application with the regulatory authority in India after the government did not relent to its demand for indemnity. 

Quoting a company spokesperson, however, the Wall Street Journal reported earlier this month that India is in talks to buy 50 million doses of Pfizer-BioNTech vaccine.

What Is Full Licence & How Is It Different From EUA?

The Pfizer-BioNTech currently has an emergency use authorisation or EUA, which the FDA offers during crises so people get quick access to potentially lifesaving medicines. It is during the Covid pandemic that EUA was granted to new vaccines for the first time.

Earlier, EUAs have typically been used for drugs during “very catastrophic, immediate circumstances, like an anthrax attack”, according to former FDA chief scientist Jesse Goodman, who is now with Georgetown University.

It is the scale that makes all the difference between an EUA and a full approval.

Full approval is an “exhaustive review”, Goodman told Science magazine.

FDA reviews much more data, which takes a longer time, before it grants full approval to a vaccine or drug.

For a full approval, the FDA analyses additional clinical trial data, and also studies real-world data on effectiveness of the vaccine or drug and safety. It also inspects the manufacturing facilities to check for the standards of quality control.

“It’s not a huge difference, but it is a real difference,” Goodman said. 

FDA had accepted Pfizer’s application for full approval “under priority review” on July 16 this year.

What Does Full Approval Mean For Vaccines?

A full approval to the Pfizer vaccine could pave the way for many vaccination requirements by public and private organisations as they were awaiting this before making the inoculation mandatory.

A large number of universities and high-profile hospitals in the US have already made it a rule that staff and students must be vaccinated, but there are also many organisations that are hesitant to do so as the vaccines are still awaiting full approval. 

US officials also believe the full approval will also help fight the hesitancy as many Americans are reluctant to take a vaccine that was only authorised for emergency use, a recent polling suggested.

“Some people who understand that the ‘E’ in ‘EUA’ stands for ‘emergency’ are waiting for full FDA approval before they receive a shot,” Eric Topol, director of the Scripps Research Translational Institute, wrote in an op-ed in NYT in July. 

A survey of nearly 2,000 adults conducted by the Kaiser Family Foundation in June found that about 30 per cent of the unvaccinated people were waiting for the vaccines to receive full approval.