US approval of Pfizer Covid-19 vaccine 'should spur uptake in SA'

25 August 2021 - 06:00 By paul ash
The US drug regulator granted full approval to the Pfizer Inc/BioNTech SE Covid-19 vaccine on Monday.
The US drug regulator granted full approval to the Pfizer Inc/BioNTech SE Covid-19 vaccine on Monday.

The US Food and Drug Administration (FDA) granted full approval of Pfizer-BioNTech's Covid-19 vaccine on Monday, paving the way for greater public confidence in the jab.

The FDA approved use of the vaccine for people 16 and older, making it the first vaccine to move beyond emergency-use status in the US.

The result would likely boost public confidence on the vaccine's safety and efficacy, said Prof Helen Rees, executive director of the Wits Reproductive Health Institute and member of the ministerial advisory committee on vaccines.

“Full licensing will hopefully give another level of reassurance,” she said.

Rees noted that while data on the vaccine's efficacy and safety has been available for some time, full approval was the regulatory step that other countries needed to fully approve the vaccine.

“This is a positive development,” said Stavros Nicolaou, Business for SA health working group chairperson. “It demonstrates to the rest of the world that the vaccine is effective.”

The Pfizer-BioNTech vaccine, which will now be marketed as Cominarty, had been offered under emergency use authorisation for people older than 16 since December 2020 and expanded to those over 12 since May 10.

Emergency use approval is allowed under FDA rules during public health emergencies to allow products that could be used to combat such crises as a disease outbreak, provided that the product's benefits outweigh its risks, the FDA said.

Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

“We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Cominarty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities.” 

Dr Morena Makhoana , CEO of Cape Town-based pharmaceutical company Biovac, said FDA approval of other vaccines would probably follow hot on Cominarty's heels.

“Most Covid-19 vaccines are likely to be fully registered in time provided that they furnish regulators with the required data and we are likely to see many of them moving from emergency use approval to being fully registered,” he said.

How quickly this would happen would depend on what regulators required from each submission, he cautioned.

.“I don't know how quickly SAHPRA will do so locally but that is for them to answer.”

Makhoana predicted the FDA approval would have little effect on SA's vaccine rollout.

“It should have minimal affect,” he said. “Pfizer supplies have been consistent and we expect that it stays that way.”

Meanwhile, the FDA approval will likely result in US authorities enforcing vaccine mandates.

US defence secretary Lloyd J Austin is expected to require the country's 1.4-million active-duty service members to get the jab, the New York Times reported.

Oregon has also said all state workers must be vaccinated, while New York mayor Bill de Blasio said all education department employees must be vaccinated by September and would not have the option of having Covid-19 tests instead, the paper added.



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