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.
The US mass vaccination will begin on December 14 after it was authorized for emergency use, officials say.
The first three million doses of the Pfizer/BioNTech coronavirus vaccine would be shipped “across all states” this weekend, said General Gustave Perna, who is overseeing distribution.
The vaccine offers up to 95% protection against Covid-19 and was deemed safe by the FDA.
On December 12, the US recorded a daily toll of 3,309 Covid-related deaths.
The figure, reported on the Johns Hopkins University website, is the highest total in a single day anywhere in the world.Coronavirus deaths have been rising sharply since November in the US.
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:
Hospitals
Vaccination centers
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.
Pfizer and BioNTech are filing for emergency authorization in the US of their Covid-19 vaccine on Friday, November 20.
The FDA will decide if the vaccine is safe to roll out.
It is not clear how long the FDA will take to study the data. However, the US government expects to approve the vaccine in the first half of December.
Data from an advanced trial showed the vaccine protects 94% of adults over 65.
Pfizer’s and BioNTech’s trial involved 41,000 people worldwide. Half were given the vaccine, and half a placebo.
If FDA authorization does come in the first half of next month, Pfizer and BioNTech will “be ready to distribute the vaccine candidate within hours”, the two companies said.
This would be remarkably quick for vaccine development – within 10 months of detailing the genetic code. The average wait for approval in the US is nearer eight years.
On November 19, Pfizer CEO Albert Bourla said that the filing for emergency use was a “milestone in our journey to deliver a Covid-19 vaccine to the world”.
Initial doses would be scarce, though, and the Centers for Disease Control and Prevention (CDCP) will decide who is first in line.
European Commission president Ursula von der Leyen said the EU could move quickly too – by the end of the year.
Data released this week suggested the Pfizer and BioNTech vaccine had 95% effectiveness.
This effectiveness was also consistent across age groups – essential given the vulnerability of the elderly – as well as ethnicities and gender.
The vaccine also had only mild-to-moderate and short-lived side-effects.
It uses an experimental approach, called mRNA, which involves injecting part of the virus’s genetic code into the body to train the immune system.
Antibodies and T-cells are then made by the body to fight the coronavirus.
The US this week passed 250,000 deaths in the coronavirus outbreak, by far the largest number in the world.
Its confirmed cases since the pandemic began stand at 11.7 million, according to Johns Hopkins University research, again a global first.
Cases have also been soaring over the past week, reaching record daily highs.
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