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 widely held view is that vaccines will still work, but researchers are on the hunt for proof.
The study focuses on a mutation called N501Y, which is emerged in both new variants.
This is thought to be important because it is in the part of the virus that makes first contact with our body’s cells and changes could make it easier to get in and cause an infection.
The researchers created two forms of the virus – one with and one without the mutation – and then bathed those viruses in blood samples taken from 20 patients that had been vaccinated in clinical trials.
The study results showed the immune systems of vaccinated patients were able to take out the new mutation.
However, the variant that emerged contain multiple mutations whose combined effects may help the virus evade the immune system.
Ursula von der Leyen tweeted: “Today, we start turning the page on a difficult year. The #COVID19 vaccine has been delivered to all EU countries. Vaccination will begin tomorrow across the EU. The #EUvaccinationdays are a touching moment of unity. Vaccination is the lasting way out of the pandemic.”
German Health Minister Jens Spahn said on December 26: “This really is a happy Christmas message. At this moment, trucks with the first vaccines are on the road all over Europe, all over Germany, in all federal states. Further deliveries will follow the day after tomorrow.
“This vaccine is the crucial key for defeating the pandemic. It’s the key for us getting back our lives.”
Health workers in north-east Germany decided not to wait for December 27 and started immunizing elderly residents of a nursing home in Halberstadt.
The authorities in Slovakia also said they had begun vaccinating.
Italian Foreign Minister Luigi Di Maio urged his compatriots to get the vaccine: “We’ll get our freedom back, we’ll be able to embrace again.”
In Hungary, the first recipient of the vaccine was a doctor at Del-Pest Central Hospital on December 26, the state news agency says.
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.
Privacy & Cookies Policy
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.