BREAKING: Pfizer is Now Seeking FDA Approval of ‘Booster Shots’ – for Teenagers

Pfizer-BioNTech is pressing for further expansion of its “booster shots” market to include teenagers, according to new reports by the Washington Post and New York Times.



“Pfizer and BioNTech are expected this week to apply for regulatory approval for a booster shot of their coronavirus vaccine for 16- and 17-year-olds, according to people familiar with the company’s plans,’ the Times reported. “If approved, the shot would be the first booster available to people under 18.”

The FDA could authorize extra shots within roughly a week, the report noted. Meanwhile, President Biden is calling the new Omicron variant “a cause for concern, not a cause for panic.”

“I’m sparing no effort, removing all roadblocks to keep the American people safe,” Biden said.

As reported earlier, it appears from initial medical reports that Omicron’s effects have predominatedly been “mild.”

“Covid symptoms linked to the new omicron variant have been described as ‘extremely mild’ by the South African doctor who first raised the alarm over the new strain,” CNBC reported.

Should USA get involved with Ukraine?*
This poll gives you free access to our premium politics newsletter. Unsubscribe at any time.
This field is for validation purposes and should be left unchanged.

“Dr. Angelique Coetzee, chair of the South African Medical Association, told the BBC on Sunday that she started to see patients around Nov.18 presenting with ‘unusual symptoms’ that differed slightly from those associated with the delta variant, which is the most virulent strain of the virus to date and globally dominant,” the report added.

“It actually started with a male patient who’s around the age of 33 … and he said to me that he’s just [been] extremely tired for the past few days and he’s got these body aches and pains with a bit of a headache,” she told the BBC.

“The patient didn’t have a sore throat, she said, but more of a ‘scratchy throat’ but no cough or loss of taste or smell — symptoms that have been associated with previous strains of the coronavirus,” the report added.

Meanwhile, medical experts are now indicating they are “confident” they can rapidly develop a vaccine specifically for the Omicron variant of Covid-19.

“BREAKING: Medical professionals tell FoxBusiness sources inside big pharma are confident they can make a vax specifically for Omicron Variant and can produce it fairly quickly,” journalist Charles Gasparino tweeted. “They are first waiting on data about its virulence and whether it evades current vaxs. Developing…”

As reported earlier, Pfizer-BioNTech is considering a “relaunch” of its vaccines due to the Omicron variant, which is spreading through previously low Covid incidence and highly unvaccinated nations in Africa.

“BioNTech SE said on Friday it expects more data on a worrying new coronavirus variant detected in South Africa within two weeks to help determine whether its vaccine produced with partner Pfizer Inc would have to be reworked,” Reuters reported.

“Pfizer and BioNTech said that if necessary they expect to be able to ship a new vaccine tailored to the emerging variant in approximately 100 days,” the report added.

“We understand the concern of experts and have immediately initiated investigations on variant B.1.1.529,” BioNTech said in a statement.

“We expect more data from the laboratory tests in two weeks at the latest. These data will provide more information about whether B.1.1.529 could be an escape variant that may require an adjustment of our vaccine if the variant spreads globally,” it added.

“Moderna Inc said in a statement it is working to advance a booster candidate tailored to the new variant and has also been testing a higher dose of its existing booster and to study other booster candidates designed to protect against multiple variants,” the report continued.

“A booster dose of an authorized vaccine represents the only currently available strategy for boosting waning immunity,” Moderna said in the statement.

“Those efforts are not meant to yield commercial products; the exercise is carried out to establish a routine with regulators that will help speed up any future vaccine relaunch,” Reuters noted.

Amid the reports of the Omicron variant, BioNTech ADRs gained 14.2% to close at $348 on Friday and Pfizer shares rose 6.1% to end at $54. Moderna gained 20.6% to close at $329.63.

Yet another company, Novavax, said on Friday it has “started working on a version of its COVID-19 vaccine to target the variant detected in South Africa” and “would have the shot ready for testing and manufacturing in the next few weeks,” Reuters also reported.

“The company’s COVID-19 shot contains an actual version of the virus’ spike protein that cannot cause disease but can trigger the immune system,” Reuters noted. “The vaccine developer said it had started developing a spike protein specifically based on the known genetic sequence of the variant, B.1.1.529.”

“The initial work will take a few weeks,” a company spokesperson said. “Shares of the company closed up nearly 9% on Friday.”

The report notes that Novavax’s vaccine received its first emergency use approval earlier this month in Indonesia, followed by the Philippines.

“The company has said it is on track to file for U.S. approval by the end of the year,” the report continued. “It has also filed for approvals with the European Medicines Agency as well as in Canada.”

“German drugmaker BioNTech SE and Johnson & Johnson have also said they were testing the effectiveness of their respective COVID-19 vaccines against the new variant,” the report added.

In June, a Centers for Disease Control advisory group released a statement on the ‘likely link’ between COVID-19 vaccinations and heart inflammation in rare cases.

The COVID-19 Vaccine Safety Technical (VaST) Work Group noted the adverse reaction in vaccinated males between the ages of 16 and 24. The development of the heart condition was observed in adolescents and young adults and was considerably higher after the second dose in males.

Earlier, the Centers for Disease Control and Prevention endorsed the use of the experimental Pfizer-BioNTech coronavirus vaccines in children as young as 5.

Syndicated with licensed permission from Becker News. Follow Becker News on Telegram.