DISCLOSURE: Pfizer Now Seeks FDA Approval of ‘Strengthed Shot’ – for Teens

According to a new report by the Washington Post and New York Times, Pfizer-BioNTech is pushing to further expand the “enhanced” market to include teenagers.

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

According to the report, the FDA may authorize further injections within about a week. Meanwhile, President Biden called the new Omicron variant “a cause for concern, not a cause for panic”.

“I spared no effort, removing all barriers to keep the American people safe,” Biden said.

As previously reported, it seems from early medical reports that the effects of Omicron are mostly “mild”.

“Covid symptoms associated with the new omicron variant have been described as ‘extremely mild’ by the South African doctor who first raised the alarm about the new strain of bacteria,” CNBC reported.

“NS. Angelique Coetzee, president of the South African Medical Association, told BBC on Sunday that she started seeing patients around 18 November presenting with ‘unusual symptoms’ that were slightly different from those associated with the delta variant, which is the only virus strain to date and dominate globally,” the report added.

“It really started with a male patient about 33 years old… and he told me he just [been] She’s been very tired for the last few days and he has body aches accompanied by a bit of a headache,” she told the BBC.

The report added: “The patient did not have a sore throat, which resembled an ‘itchy throat’ but without cough, loss of taste or smell – symptoms associated with previous strains of coronavirus,” the report added. know more.

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

“BREAKING: Medical experts tell FoxBusiness sources inside major pharmaceutical companies are confident they can create a vax specifically for Omicron Variant and be able to produce it fairly quickly,” says journalist Charles Gasparino tweeted. “First, they are waiting for data on its virulence and whether it avoids the current vax. Developing… “

As previously reported, Pfizer-BioNTech is considering a “relaunch” of its vaccine due to the Omicron variant, which is spreading through previously low Covid rates and unvaccinated countries high in Africa.

“BioNTech SE said on Friday that it hopes to have more data on a disturbing new coronavirus variant discovered in South Africa within two weeks to help determine whether its vaccine was made against Pfizer Inc must be reworked,” Reuters reported.

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

“We understood the experts’ concerns and immediately began investigating variant B.1.1.529,” BioNTech said in a statement.

“We expect more data from laboratory trials in two weeks at the latest. These data will provide further information on whether B.1.1.529 could be an exit variant and may require our vaccine adjustment if this variant spreads globally. ‘ it added.

“Moderna Inc said in a statement that it is working to promote a suitable booster candidate for the new variant and has also tested higher dosages of its existing enhancer and to study other enhancement candidates are designed to protect against multiple variants,” the report continued.

“A booster dose of an authorized vaccine represents the only strategy currently available to boost attenuated immunity,” Moderna said in the statement.

“Those efforts are not intended to bring about a commercial product; The exercise was conducted to establish a routine with regulators that will help speed up any future vaccine relaunch,” Reuters noted.

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

Yet another company, Novavax, said on Friday that it had “started work on a version of its COVID-19 vaccine to target the variant discovered in South Africa” ​​and ” will have this vaccine ready for testing and production in the next few weeks,” Reuters also reported.

The company’s COVID-19 snapshot contains a real-life version of the mutant protein of the virus that cannot cause disease but can activate the immune system. “The vaccine developer says they have begun developing a special mutant protein based on the known genetic sequence of the variant, B.1.1.529.”

A company spokesman said: “Initial work will take several weeks. “The company’s shares 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 said it is on track to apply for US approval later this year,” the report continued. “It has also been submitted for approval with the European Medicines Agency as well as in Canada.”

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

In June, a Center for Disease Control advisory group released a declare about a ‘likely link’ between COVID-19 vaccination and heart inflammation in rare cases.

The COVID-19 Vaccine Safety Engineering (VaST) Working Group has documented adverse reactions in vaccinated males between the ages of 16 and 24. Development of cardiac conditions was observed in young adults. adolescents and young adults and was significantly higher after the second dose in men.

Earlier, the Centers for Disease Control and Prevention confirmed the use of an experimental Pfizer-BioNTech coronavirus vaccine in children under 5 years of age.

https://smartzune.com/breaking-pfizer-is-now-seeking-fda-approval-of-booster-shots-for-teenagers/ DISCLOSURE: Pfizer Now Seeks FDA Approval of ‘Strengthed Shot’ – for Teens

Huynh Nguyen

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