US gives full approval to Pfizer Covid-19 vaccine
The Pfizer vaccine was yesterday given full approval by US authorities.
The Food and Drug Administration gave the vaccine its strongest endorsement on the grounds of the massive amount of evidence that it is safe.
Janet Woodcock, the acting FDA commissioner, said: “The public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product.”
Kim Wilson, the health minister, said: “This is welcoming news as we continue to provide the COVID-19 vaccine for a safer community.
“This is excellent news for those individuals who have delayed getting vaccinated until the FDA fully approved the vaccine.”
She added: “I hope this move will encourage people to get vaccinated as soon as possible.”
Ayo Oyinloye, the Chief Medical Officer, said: “I urge all unvaccinated persons to please get vaccinated as this is primarily our best tool to move beyond the pandemic.
“The majority of our local coronavirus cases are unvaccinated and our numbers are rising.”
Dr Oyinloye added the supply of the Pfizer vaccine would expire in October and the last first dose would be on October 10, but that more vaccine could be obtained if there was a demand.
Ms Wilson highlighted that countries such as Canada would require vaccination for overseas visitors and that a US plan to require most foreign visitors to be fully vaccinated was in the works.
Michael Dunkley, the Opposition health spokesman, said the One Bermuda Alliance was pleased by the US announcement.
Mr Dunkley added the approval, for people aged 16 and over, was “a key public health achievement”.
The existing US emergency approval for children aged 12 to 15 remains in force.
Mr Dunkley said he backed the view that “the FDA approval of a vaccine may now instil additional confidence to get vaccinated”.
He added: “We hope this proves true in Bermuda as we still have not reached the desired vaccination rates.
“Those who have some hesitancy should take comfort in this major announcement as we continue to tackle the impact of the virus on our community.”
The approval came as the US battled the Delta variant – the most contagious variant of the coronavirus yet seen.
More than 200 million Pfizer doses have been administered in the US – and hundreds of millions more worldwide – since last December.
But they were dispensed in America and in other countries under emergency use authorisation.
The shot will now be known in the US by the brand name Comirnaty.
Just over half of the US population is fully vaccinated with one of the country’s three options – Pfizer, Moderna or Johnson & Johnson jabs.
Moderna has also applied to the FDA for full approval of its vaccine and J&J said it hoped to do so later this year.
Jesse Goodman, of Georgetown University and a former FDA vaccine chief, said the stamp of approval meant Pfizer's vaccine met the same “very high standards required of all the approved vaccines we rely on every day”.
The Pentagon announced after the FDA approval that it would press ahead with plans to require members of the military to get the vaccine.
The FDA’s ruling may also lead to more vaccine mandates for students, employees and customers.
Carlos del Rio of Emory University, said: Mandating becomes much easier when you have full approval.
“I think a lot of businesses have been waiting for it.”
New York City, New Orleans and San Francisco imposed proof-of-vaccination requirements at restaurants, bars and other indoor venues earlier this month.
President Biden has required US government workers to sign forms to show that they have been vaccinated or submitted to regular testing and other requirements.
Almost six in 10 US citizens in a recent survey said people should be fully vaccinated before they could travel by air or attend large public events.
The FDA, like regulators in Europe and much of the world, allowed emergency use of Pfizer’s vaccine based on a study that tracked 44,000 people aged 16 and older for at least two months.
The time frame is when serious side effects typically arise and is shorter than the six months of safety data normally required for full approval.
Pfizer kept that study going and the FDA also examined real-world safety evidence before it made its decision.
US government tracking has shown serious side effects, such as chest pain and heart inflammation a few days after the second dose, mostly in young men, is very rare.
The vaccine has been found to be 97 per cent protective against severe Covid-19.
But protection against milder infection decreased slightly, from a peak of 96 per cent two months after the second dose to 84 per cent by six months.
The FDA will look at approval for booster doses, which will be decided separately.
Emergency use of a third dose of either the Pfizer or Moderna vaccine is allowed in the US for people with weakened immune systems, such as organ transplant recipients or cancer patients.
The Biden administration is planning to start boosters of the two vaccines in the autumn if the FDA and the US Centres for Disease Control agree.
The vaccination of children aged under 12 with the Pfizer and Moderna shots is still under consideration.