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Report: Final Approval of Pfizer COVID-19 Vaccine in U.S. Set for Monday


FILE - A nurse prepares a dose of the Pfizer COVID-19 vaccine at a clinic at Providence Wilmington Wellness and Activity Center, July 29, 2021, in Wilmington, Calif.

The U.S. Food and Drug Administration reportedly intends to grant full approval to Pfizer’s COVID-19 vaccine on Monday.

The New York Times said the agency had planned to complete the approval by Friday but still faced “a substantial amount of paperwork and negotiation with the company.”

The FDA, which the Times said had previously set an unofficial approval deadline of about September 6, declined to comment.

Final approval could bolster the Biden administration’s vaccination program by convincing unvaccinated citizens that Pfizer’s vaccine is safe and effective while also easing concerns among local officials about vaccine mandates.

Elsewhere, Reuters reported Friday that authorities in India had approved emergency use of a second locally developed vaccine, while British drugmaker AstraZeneca unveiled a new antibody therapy to fight COVID-19.

India’s latest vaccine, developed by Indian pharmaceutical firm Zydus Cadila, is the world's first DNA-based inoculation against the coronavirus. The vaccine uses a section of genetic material from the virus to instruct cells to make a specific protein to which the immune system can respond.

The three-dose vaccine has been approved for use in adults as well as children 12 and older. It is the sixth vaccine to be approved in India, including another locally developed vaccine by Indian firm Bharat Biotech.

New antibody therapy

AstraZeneca on Friday released data from a late-stage trial for a new antibody therapy, showing it reduced the risk of people developing any COVID-19 symptoms by 77%. The company said the therapy could be used preventatively and could be particularly helpful to people who respond poorly to immunization shots. It said that 75% of the participants in the trial had chronic conditions, including some with a lower immune response to vaccinations.

In South Africa on Friday, officials opened vaccine eligibility to all adults as they sought to protect the population from a surge fueled by the highly contagious delta variant.

Thousands of protesters took to the streets of France for a sixth straight Saturday against a new COVID-19 health pass that is needed to enter restaurants and other eating establishments, entertainment venues and long-distance travel.

The protesters see the pass as a restriction of their freedom in a country of more than 60 million people, more than 60% of whom have been fully vaccinated.

In Australia, police clashed Saturday with COVID-19 lockdown protesters in Melbourne. Police said more than 4,000 people attended the demonstration. Six police officers were taken to the hospital for injuries and more than 200 protesters were arrested. A much smaller protest was held in Sydney, drawing about 250 demonstrators, according to the Sydney Morning Herald. Forty-seven people were arrested at the Sydney rally.

Sri Lankan action

Sri Lanka began a 10-day lockdown on Friday in an effort to limit the spread of the coronavirus. The nation recorded its highest single-day COVID-19 death toll of 187 on Wednesday.

In Israel, Prime Minister Naftali Bennett received a third shot of the Pfizer-BioNtech COVID-19 vaccine on Friday, as the country began administering additional shots to people ages 40 and older to combat an increase in coronavirus infections.

The United States on Friday extended the closure of its land borders with Canada and Mexico for nonessential travel through September 21. The move came despite Canada’s decision to open its border to vaccinated Americans.

Officials in San Francisco on Friday began a program of requiring proof of full vaccination against the coronavirus from those entering indoor restaurants, gyms and concert halls. The city is the first major U.S. metropolitan area to require full vaccination at such venues and goes further than a New York rule, which requires people to be at least partially vaccinated to attend many indoor activities.

Some information for this report came from The Associated Press, Agence France-Presse and Reuters.

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