Some more lines from Reuters on the FDA approval.
- In Pfizer’s clinical trial, approximately 12,000 recipients of the vaccine have been followed for at least six months.
- The FDA’s approval extends the shelf life of Pfizer shots from six months to nine months.
- It also confirms that the vaccine increases risk of heart inflammation, particularly among young men in the week following their second shot.
- The Pentagon said it is preparing to make the vaccine mandatory for US military personnel.
- The approval makes it easier for physicians to prescribe a third dose of Pfizer’s vaccine off-label for people who may benefit from additional protection.
- The FDA is not recommending that children under age 12 get the vaccine because there is not “proper data” proving its safety.
- Pfizer is expected to submit data this fall to support the shot’s emergency-use authorisation for children under 12 based on smaller doses.
- The American Academy of Pediatrics, representing children’s doctors, discouraged having children under 12 receive the vaccine.
- Pfizer shares were up around 2.5% and BioNTech shares were up more than 10%.
The full approval of the Pfizer jab in the US “should give added confidence” that it is safe and effective, president Joe Biden has said.
However, experts have warned of concerns that general authorisation was made behind closed doors based on six months worth of data despite trials being designed for two years – making it an extremely rare case for a mass use vaccine.
“There is no control group after Pfizer offered the product to placebo participants before the trials were completed,” Kim Witczak, a drug safety advocate on the FDA’s psychopharmacologic drugs advisory committee told the BMJ.
“Full approval of Covid-19 vaccines must be done in an open public forum for all to see. It could set a precedent of lowered standards for future vaccine approvals.”
But the acting FDA commissioner, Janet Woodcock, who described approval of the vaccine as “a milestone as we continue to battle the Covid-19 pandemic”, said the data met its standards.
While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorisation, as the first FDA-approved Covid-19 vaccine, 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.
President Biden (@POTUS)
The FDA has officially approved the Pfizer COVID-19 vaccine. While all three COVID vaccines have met FDA’s strict standards for emergency use, this FDA approval should give added confidence that this vaccine is safe and effective.
If you’re not vaccinated yet, now is the time. https://t.co/XaxFdWHbRc
As we reported last week here on the blog, the BBC reports that Chinese state media have increasingly been pushing a campaign which falsely claims Covid-19 originated in the US – in an attempt to distract from growing scrutiny over virology labs in Wuhan.
Ahead of the release of a US intelligence investigation, following a congressional report which included circumstantial evidence implying a lab leak was at least plausible, Chinese propagandists have pushed a conspiracy suggesting that Covid was made and leaked from an American military base in Maryland, about 80 km north of Washington DC.
The BBC reports that it was previously the centre of the US biological weapons programme and now houses biomedical labs researching viruses including Ebola and smallpox. Experts suggest the campaign has succeeded in convincing many Chinese people.
“For the most part, the biggest concern [of the Chinese government] is domestic legitimacy,” Georgia State University global communication assistant professor Maria Repnikova told the BBC.
Zhao Lijian, the Chinese foreign ministry spokesman, recently backed a rap song by a Chinese nationalist group suggesting dastardly plots were cooked up in the facility.
With growing western coverage over the origin of the virus, with a Channel 4 documentary last night posing the question – did Covid-19 leak from a lab in China – the superpower’s media machine has been on the offensive.
The Chinese state broadcaster CCTV has aired a special report, “The Dark History behind Fort Detrick”, focusing on containment breaches at the lab in 2019, to reinforce claims of poor lab security made by Chinese officials, the BBC reports.
Channel 4 Dispatches (@C4Dispatches)
A global pandemic. A maze of unanswered questions.
The lethal cost of Covid-19 has been felt around the world – but where did the virus come from? Did it leak from a lab, or is that just a conspiracy theory? #CovidLeak?
Tonight at 10.15 on @Channel4 1/ pic.twitter.com/ZuIF8zREIB
Florida’s battle over school mask mandates has reached the governor’s doorstep after education leaders in the state capital, Tallahassee, became the latest to defy Ron DeSantis’s ban.
Rocky Hanna, superintendent of the Leon county school district, announced yesterday that masks would be required to be worn by students in pre-kindergarten to eighth grade, beginning today. Only medical exemptions will be allowed.
Anti-vaccine protesters occupied the headquarters of ITV News and Channel 4 News in London on Monday afternoon, the latest in a series of actions aimed at the media.
Jon Snow, the Channel 4 News presenter, was chased into one of the building’s side entrances by conspiracy theorists shouting at him.
Livestream footage showed hundreds of protesters shouting scientifically unsupported claims about the Covid-19 vaccine programme and blaming the media for promoting so-called vaccine passports, which they view as incompatible with British values.
Italy has reported 44 coronavirus-related deaths on Monday, compared with 23 the day before, the health ministry said, while the daily tally of new infections fell to 4,168 from 5,923.
Rueters reports Italy has registered 128,795 deaths linked to Covid since its outbreak emerged in February last year, the second-highest toll in Europe after Britain and the eighth-highest in the world. The country has reported 4.49m cases to date.
Patients in hospital with Covid – not including those in intensive care – stood at 3,928 on Monday, up from 3,767 a day earlier.
There were 45 new admissions to intensive care units, up from 33 on Sunday. The total number of intensive care patients increased to 485 from a previous 472.
Some 101,341 tests for Covid were carried out in the past day, compared with a previous 175,539, the health ministry said.
China’s health authority has reported no new locally transmitted symptomatic Covid cases for the first time since the recent Delta variant outbreak began in July.
While it is unclear whether the figure will remain at zero in the weeks to come, experts said it was yet another sign that Beijing’s tough “zero tolerance” approach was unlikely to be changed.
More than 1,200 people have been confirmed infected in an outbreak that officials said was mainly driven by the highly transmissible Delta variant, which was brought in from abroad and caused a cluster in late July in the eastern city of Nanjing.
In the UK, 31,914 people have tested positive for Covid in the last 24 hours.
A further 40 people have died within 28 days of testing positive for coronavirus, according to the latest update to the government’s coronavirus dashboard on Monday.
Official figures showed another 40,345 people had their first dose of a Covid vaccine, with 116,352 getting their second jab. This means almost 77% of the adult population are fully vaccinated.
Following the full US approval for the Pfizer jab, New York City officials have been first to announce a vaccine mandate for school employees – in what is expected to be a flurry of such moves across the country.
The Associated Press reports that officials have said all New York City public school teachers and other staffers will have to get vaccinated against the coronavirus as the nation’s largest school system prepares for classes to start next month.
The city previously said teachers, like other city employees, would have to get the shots or get tested weekly for the virus. The new policy marks the first no-option vaccination mandate for a broad group of city workers in the nation’s most populous city, though mayor Bill de Blasio announced on Friday that coaches and students in football, basketball and other purportedly “high-risk” sports would have to get inoculated before play begins.
Now, about 148,000 school employees – and contractors who work in schools – would have to get at least a first dose by 27 September, according to an announcement from the Democratic mayor and the city health and education departments.
The city has not immediately said what the penalty will be for refusing, or whether there will be exemptions. The previous vaccinate-or-test requirement had provisions for unpaid suspensions for workers who did not comply.
At least 63% of school employees have been vaccinated. That figure doesn’t include those who may have gotten their shots outside the city.
New York City last week began requiring proof of vaccination t o enter restaurant dining rooms, gyms and many other public places, a first-in-the-nation policy that a few other cities have copied since it was announced. Meanwhile, New York state announced last week that hospital and nursing home workers would have to get inoculated, the AP reports.
Berlin nightclubs are set to reopen after a court repealed a blanket ban on dance events in closed rooms in the German capital, but only for the vaccinated or those who have recently recovered from Covid.
After a nightclub owner sued local authorities, a Berlin-Brandenburg court said that the restrictions were fair and sensible but “likely to be disproportionate” for those who have been vaccinated or recently recovered, DJ Mag reports.
However, for unvaccinated people – even with a negative test result – the ban continues to apply. The court said that an epidemic situation of national scope remained, and therefore that the regulations should continue to be generally applied, according to local media.
In other news, the Brazilian president, Jair Bolsonaro, has said that he will ask his health minister to set an end date for the use of face masks as a means of reducing Covid transmission
Reuters reports that masks have become a political issue in Brazil, with Bolsonaro long ranting against their use and frequently refusing to wear one in public despite a legal requirement to do so.
In a radio interview, the president argued that with much of the population already vaccinated or having caught the virus, masks are not needed and that he hoped a date would be set by the end of the day.
Any such move could prove to be largely moot, however, with states and municipalities free to set their own Covid-19 restrictions in Brazil. Any federal government position on the matter would likely only function as a guideline, though it would be considered a victory by Bolsonaro’s far-right base.
Some epidemiologists say it is too early for such a move, especially due to the rise of the Delta variant in Brazil. Although nearly 60% of Brazil’s population have received their first dose, only 25% are fully vaccinated.
Bolsonaro said he had also commissioned a study into the use of mask wearing with a view to recommending an end to their widespread use.
Brazil, which at over 570,000 has the world’s second highest coronavirus death toll behind only the US, has faced claims that a lack of coordinated national social distancing measures have propelled the death rate.
But the acting FDA commissioner, Janet Woodcock, who said approval of the vaccine was “a milestone as we continue to battle the Covid-19 pandemic”, said the data has met its standards.
While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorisation, as the first FDA-approved Covid-19 vaccine, 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.
While millions of people have already safely received Covid-19 vaccines, we recognise that for some, the FDA approval of a vaccine may now instil additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the US.
However, the decision to grant full approval has already met criticism. The British Medical Journal reports that the FDA should demand adequate, controlled studies with long term follow up, and make data publicly available, before authorising.
It said that Pfizer and BioNTech posted updated results for their ongoing phase 3 trial on 28 July, but without any new data and containing an identical topline efficacy result as the previous preprint – following its admission of significantly waning efficacy that it used to justify calls for booster shots.
Senior BMJ editor Peter Doshi writes:
Whatever one thinks about the ‘95% effective’ claims even the most enthusiastic commentators have acknowledged that measuring vaccine efficacy two months after dosing says little about just how long vaccine-induced immunity will last. The concern, of course, was decreased efficacy over time. ‘Waning immunity’ is a known problem for influenza vaccines, with some studies showing near zero effectiveness after just three months, meaning a vaccine taken early may ultimately provide no protection by the time ‘flu season’ arrives some months later.
If vaccine efficacy wanes over time, the crucial question becomes what level of effectiveness will the vaccine provide when a person is actually exposed to the virus? Unlike Covid vaccines, influenza vaccine performance has always been judged over a full season, not a couple months.
And so the recent reports from Israel’s ministry of health caught my eye. In early July, they reported that efficacy against infection and symptomatic disease “fell to 64%.” By late July it had fallen to 39% where Delta is the dominant strain. This is very low. For context, the FDA’s expectation is of “at least 50%” efficacy for any approvable vaccine.
He added that Pfizer allowed all trial participants to be formally de-anonymised to researchers starting last December, and placebo recipients to get vaccinated, after it received emergency approval. By 13 March, 93% of trial participants had been unblinded, officially entering “open-label followup” and therefore the preprint was based on the 7% of trial participants who remained anonymous at six months.
The US Food and Drug Administration has given full approval to the Pfizer vaccine for Covid-19. The vaccine and others have been in use under emergency use authorisation.
The decision is likely to trigger a wave of formal vaccine requirements from government departments, businesses, schools and other bodies.
Many observers hope formal approval will spur an increase in vaccine take-up among sections of the population, particularly in Republican-led states, so-far resistant to government advice.
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