FDA authorizes Pfizer’s COVID-19 vaccine for 12- to 15-year-olds

An illustration picture shows vials with COVID-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020.

Enlarge / An illustration image reveals vials with COVID-19 Vaccine stickers connected, with the emblem of US pharmaceutical firm Pfizer, on November 17, 2020. (credit score: Getty | JUSTIN TALLIS)

The US Meals and Drug Administration has licensed the usage of the Pfizer-BioNTech COVID-19 vaccine in adolescents between the ages of 12 to 15, the company introduced Monday night.

Within the announcement, performing FDA Commissioner Janet Woodcock referred to as the authorization “a big step within the struggle in opposition to the COVID-19 pandemic” that can convey the nation “nearer to returning to a way of normalcy and to ending the pandemic.”

Peter Marks, director of the FDA’s Middle for Biologics Analysis and Analysis, echoed that sentiment. He referred to as the flexibility to vaccinate kids and youths “a essential step” within the struggle in opposition to COVID-19.

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FDA reportedly plans to authorize Pfizer’s COVID vaccine for teenagers 12-15 in days

Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech.

Enlarge / Vials with COVID-19 Vaccine labels exhibiting logos of pharmaceutical firm Pfizer and German biotechnology firm BioNTech. (credit score: Getty | Photonews)

The Meals and Drug Administration is planning to authorize the usage of Pfizer-BioNTech’s COVID-19 vaccine in adolescents 12 to 15 years outdated later this week or early subsequent week, in keeping with a report by The New York Occasions.

The Occasions cited unnamed federal officers who didn’t have authorization to talk publicly in regards to the FDA’s plans. If the FDA does authorize use of the vaccine within the teen group within the week, the Facilities for Illness Management and Prevention’s vaccine advisory panel will probably meet a day later to evaluate the scientific trial knowledge and make a advice on use, the Occasions reported.

On March 31, Pfizer introduced that the vaccine fully protected adolescents ages 12 to 15 towards COVID-19 in a small Section III scientific trial. The vaccine was additionally well-tolerated within the age group, producing primarily commonplace unwanted side effects.

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Actual-world knowledge reveals vaccines kicking butt—together with towards scary variant

A healthcare worker administers a dose of the Pfizer-BioNTech Covid-19 vaccine inside the Viejas Arena on the campus of San Diego State University in San Diego, California, US on Thursday, April 1, 2021.

Enlarge / A healthcare employee administers a dose of the Pfizer-BioNTech Covid-19 vaccine contained in the Viejas Area on the campus of San Diego State College in San Diego, California, US on Thursday, April 1, 2021. (credit score: Getty | Bloomberg)

In a small trial, the Pfizer/BioNtech vaccine totally protected individuals from symptomatic COVID-19 attributable to the worrisome B.1.351 coronavirus variant extensively circulating in South Africa, the businesses introduced in a press launch.

Although researchers will want extra knowledge to verify the outcome, it’s simply the newest little bit of constructive information to come back out this week about how the vaccines are performing with real-world circumstances and in real-world settings.

On Monday, the Facilities for Illness Management and Prevention launched real-world knowledge exhibiting that the Pfizer/BioNTech mRNA vaccine and Moderna mRNA vaccine had been, collectively, 90 p.c efficient at stopping infections in totally vaccinated well being care, frontline, and important employees.

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Pfizer vaccine doesn’t want ultra-cold storage in spite of everything, firm says

A picture taken on January 15, 2021 shows a pharmacist holding with gloved hands a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19.

Enlarge / An image taken on January 15, 2021 reveals a pharmacist holding with gloved fingers a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19. (credit score: Getty | JEAN-FRANCOIS MONIER)

In a bit of fine information, Pfizer and BioNTech introduced in the present day that their extremely efficient COVID-19 vaccine doesn’t require ultra-cold storage situations in spite of everything and could be stored steady at customary freezer temperatures for 2 weeks.

The businesses have submitted information to the US Meals and Drug Administration demonstrating the hotter stability in a bid for regulatory approval to loosen up storage necessities and labeling for the vaccine.

If the FDA greenlights the change, the hotter storage situations might dramatically ease vaccine distribution, permitting doses to be despatched to non-specialized vaccine administration websites. The change would additionally make it a lot simpler to distribute the vaccine to low-income nations.

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Trump admin. agrees to pay Pfizer $1.95B for 100M extra vaccine doses

Extreme close-up photograph of fingers holding a tiny glass jar.

Enlarge / A nurse within the UK holds a vial of the Pfizer-BioNTech COVID-19 vaccine on December 22, 2020. (credit score: Lindsey Parnaby | AFP | Getty Pictures)

The Federal authorities has reached a cope with drugmaker Pfizer to safe a further 100 million doses of the Pfizer-BioNTech COVID-19 vaccine earlier than the top of July, the corporate stated at this time.

Beneath the phrases of the brand new settlement, the federal government pays $1.95 billion for the extra doses. Of the brand new vaccine doses, 70 million are due by June 30, with the remaining 30 million to be delivered no later than July 31. The settlement additionally supplies US authorities with the choice to order as much as 400 million extra doses of the vaccine later.

Well being and Human Providers Secretary Alex Azar stated in a press release that the extra Pfizer vaccine “may give Individuals much more confidence that we are going to have sufficient provide to vaccinate each American who desires it by June 2021,” when added to the 100 million doses the US authorities has already agreed to buy from Pfizer, in addition to the just lately accredited Moderna vaccine.

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We don’t have a COVID vaccine but, however distribution is already messy

A sign on the entrance to a pharmacy reads "Covid-19 Vaccine Not Yet Available," November 23, 2020 in Burbank, California.

Enlarge / An indication on the doorway to a pharmacy reads “Covid-19 Vaccine Not But Obtainable,” November 23, 2020 in Burbank, California. (credit score: Getty | Robyn Beck)

Particular person states will finally resolve who will get the primary 6.four million doses of COVID-19 vaccine, which will probably be distributed primarily based on every state’s inhabitants reasonably than the degrees of illness unfold or variety of high-risk folks.

The method, introduced in a press briefing Tuesday, is a departure from earlier plans and displays the frenzied effort to vaccinate a rustic of practically 330 million as rapidly as attainable.

Prime officers for Operation Warp Pace—the federal authorities’s program to swiftly develop and ship COVID-19 vaccines and therapies—mentioned on the briefing that the present method is meant to “maintain this straightforward.” Nevertheless, the potential for state-by-state variation in early entry to vaccines might simply turn out to be difficult—and time is ticking for states to get their distribution plans clarified. There’s only a matter of weeks earlier than the Meals and Drug Administration could grant an emergency authorization for a vaccine by Pfizer and BioNTech.

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Pfizer dashes hope for COVID-19 vaccine information earlier than the election

Albert Bourla, chief executive officer of Pfizer pharmaceutical company, bangs a gavel after ringing the closing bell at the New York Stock Exchange (NYSE) on Thursday afternoon, January 17, 2019 in New York City.

Enlarge / Albert Bourla, chief govt officer of Pfizer pharmaceutical firm, bangs a gavel after ringing the closing bell on the New York Inventory Alternate (NYSE) on Thursday afternoon, January 17, 2019 in New York Metropolis. (credit score: Getty | Drew Angerer)

Pfizer’s chief govt has dashed any lingering hope that we’ll glimpse COVID-19 vaccine information earlier than subsequent week’s election.

The pharmaceutical large has the speediest clinical-trial design among the many frontrunners within the COVID-19 vaccine race. And for weeks, Pfizer CEO Albert Bourla has dangled the chance that his firm would have outcomes by the top of October—an attractive prospect picked up by President Donald Trump, who has pushed for October vaccine information to bolster his re-election bid.

However in a name with buyers Tuesday, Bourla indicated an October launch was practically not possible now. Researchers conducting the over 40,000-person trial haven’t but analyzed preliminary information and, even when the information have been out there tomorrow, an outdoor panel would want not less than every week to investigate any outcomes, Bourla mentioned.

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COVID vaccine makers vow science—not Trump—will dictate launch timing

Woman receives an experimental COVID-19 vaccine at the University of Massachusetts Medical School in Worcester, MA on September 04, 2020, as part of a clinical trial.

Enlarge / Lady receives an experimental COVID-19 vaccine on the College of Massachusetts Medical Faculty in Worcester, MA on September 04, 2020, as a part of a scientific trial. (credit score: Getty | Boston Globe)

In a rare transfer Tuesday, 9 high pharmaceutical executives made a public pledge that they won’t prematurely launch a COVID-19 vaccine and that they are going to solely search federal approval to distribute a vaccine after rigorous moral and scientific requirements are met.

The pledge was signed by the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi. All the represented firms are engaged on a vaccine towards COVID-19 and 4—AstraZeneca, Moderna, and a three way partnership between BioNTech and Pfizer—have vaccines in part three scientific trials.

The vow seems to be a coordinated resistance to stress from the Trump administration, which is pushing for a rollout of a vaccine by November 1, simply earlier than the presidential election. Final week, the Facilities for Illness Management and Prevention informed states to be prepared to start out distributing vaccines by November 1.

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