Pfizer-BioNTech’s two-dose Covid-19 vaccine has become the first to receive full approval from the FDA.
The vaccine had initially been given emergency use authorization. Its two shots, three weeks apart, are now fully approved for those aged 16 and older.
The approval is expected to set off more vaccine mandates by employers and organizations across the US.
It comes amid lingering vaccine hesitancy among many Americans.
In a statement, the FDA said its review for approval included data from approximately 44,000 people. The vaccine, which will now be marketed as Comirnaty, was found to be 91% effective in preventing Covid disease.
Acting FDA commissioner Janet Woodcock said that the public “can be very confident” the vaccine meets high safety, effectiveness and manufacturing quality standards.
Pfizer vaccine still has emergency use authorization for children aged 12 to 15.
The vaccine is being provided at no cost to Americans.
The FDA initially gave Pfizer temporary authorization – a clearance given if the agency determines the benefits of a product outweigh potential risks during a public health emergency.
This full approval is essentially permanent. The licensing process requires companies to provide the FDA with information on how and where the product is made, as well as other clinical testing data.
Critics had been calling on the FDA to speed up this approval process as the US struggled with dropping vaccination rates earlier this year. The spread of the contagious Delta variant has already given some hard-hit regions a bump in vaccination rates in recent weeks.
While the agency took steps to increase staff and resources, it had previously said it would take six months to get the required data.
The approval ultimately came less than four months after Pfizer-BioNTech filed for licensing in early May – the fastest vaccine approval in the FDA’s more than 100 year history.
Polling data released at the end of June by the Kaiser Family Foundation found that about 30% of unvaccinated American results said they would be more likely to get a vaccine if it received full FDA approval. The number rises to nearly 50% among Americans taking a “wait and see” approach to vaccines.
In a TV address on August 23, President Joe Biden spoke directly to the “millions” of Americans he said were waiting for full and final FDA approval.
“The moment you’ve been waiting for is here,” he said.
“It’s time for you to go get your vaccination. Get it today.”
Additionally, President Biden called on private sector companies and nonprofits to require employees to get vaccinated or “face strict requirements”.
Companies, healthcare systems, universities and other organizations are now expected to announce vaccine requirements as the country embarks on a return to normalcy. The US military has also said the vaccine will become mandatory for 1.3 million active-duty troops upon FDA approval.
To date, more than 92 million vaccinated Americans – more than half of the total – have received the Pfizer vaccine.
Authorizing the emergency use of the Pfizer/BioNTech vaccine on December 11, the FDA – which had come under intense pressure from the Trump administration to do so – said the move was a “significant milestone” in the pandemic.
During a news conference on December 12, Gen. Perna – speaking for the government’s vaccination campaign Operation Warp Speed – said doses of the vaccine would be packed into shipping containers for transportation “within the next 24 hours”.
He said: “Expect 145 sites across the states to receive the vaccine on Monday, another 425 sites on Tuesday, and the final 66 sites on Wednesday.”
He also said that next week’s distribution would complete the initial delivery of the Pfizer/BioNTech vaccine and cover about three million people.
Gen. Perna told reporters he was “100% confident” that the doses “needed to defeat the enemy Covid” would be transported safely.
However, he warned that while it had been a week of progress, “we are not done until every American has access to a vaccine”.
The Pfizer vaccine has already received regulatory approval in the UK, Canada, Bahrain and Saudi Arabia. Like those countries, US health authorities are expected to prioritize health workers and care home residents for the first doses.
More Americans outside the highest-priority groups are likely to be able to get the vaccine in January, with general availability expected by April.
On December 10, medical experts advising the FDA recommended the emergency-use authorization. A 23-member panel concluded the vaccine’s benefits outweighed its risks.
Emergency use, the FDA said, was not the same as full approval, which would require Pfizer to file a separate application to secure.
The Pfizer/BioNTech product was the first coronavirus vaccine to show promising results in the latter stages of its testing process.
It is a new type called an mRNA vaccine that uses a tiny fragment of genetic code from the pandemic virus to teach the body how to fight Covid-19 and build immunity.
The FDA said: “The vaccine contains a small piece of the [Covid-19] virus’s mRNA that instructs cells in the body to make the virus’s distinctive ‘spike’ protein.”
Elderly people in care homes and care home staff are top of the priority list, followed by over-80s and health and care staff.
However, because of the limited stocks and need to store at -70C, the very first vaccinations are likely to take place at hospitals so care home residents may not be immunized until later.
The Pfizer/BioNTech product is the fastest vaccine to go from concept to reality, taking only 10 months to follow the same steps that normally span 10 years.
The UK has already ordered 40 million doses of the free jab – enough to vaccinate 20 million people.
The doses will be rolled out as quickly as they can be made by Pfizer in Belgium, Matt Hancock said, with the first load next week and then “several millions” throughout December.
UK’s PM Boris Johnson said: “It’s the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again.”
Pfizer/BioNTech vaccine will be non-compulsory and there will be three ways of vaccinating people across the UK:
In the community, with GPs and pharmacists.
Around 50 hospitals are on stand-by and vaccination centers – in venues such as conference centers or sports stadiums – are being set up now.
Because the initial doses are being delivered to hospitals, which already have the facilities to store the vaccine at -70C, the very first vaccinations are likely to take place at hospital hubs – for care home staff, NHS staff and patients – so none of the vaccine is wasted.
It is thought the vaccination network could start delivering more than one million doses a week once enough doses are available.
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