CDC advisory committee recommends COVID vaccine for 12- to 15-year-olds

A masked child watches a healthcare worker perform an injection.

Enlarge / With new knowledge, we’re in a position to broaden vaccinations to ever-younger populations. (credit score: Roberto Jimenez Mejias / Getty Photographs)

On Wednesday, the CDC’s Advisory Committee on Immunization Practices really helpful that the CDC approve the usage of the Pfizer/BioNTech COVID-19 vaccine for the 12- to 15-year age group. The choice comes two days after the FDA granted an emergency use authorization for a similar age group and can assist the US additional restrict the pool of people that can unfold infections or foster the evolution of recent viral variants. Formal CDC approval might come rapidly, given current historical past.

Given the FDA’s earlier determination, the transfer might sound anticlimactic. However having the FDA and CDC formally on the identical web page is reassuring, and a number of other state-run vaccination applications are awaiting the CDC’s OK earlier than increasing into that age group. Personal suppliers and insurance coverage firms have been additionally diverse of their response to the FDA’s determination and have been ready for the CDC.

The info that supported the approval was fairly decisive, as a small Part III medical trial of two,260 adolescents noticed 16 instances of COVID-19, with each single one occurring within the placebo group. Negative effects have been much like these skilled by older individuals, with a short interval of flu-like signs. The committee was tasked with contemplating whether or not the advantages outweighed the dangers; given the minor unwanted side effects and the more and more apparent advantages of vaccination, it is not a shock that the vote in favor of approval by the committee was 14 in favor, none opposing, and a single recusal. The CDC director, Rochelle Walensky, is overwhelmingly more likely to observe the committee’s advice, almost certainly earlier than the day is over. (We’ll replace this story if and when this happens.)

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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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Contractor that ruined 15M doses of J&J vaccine is holding up vaccine to India

Funeral pyres of people who died of COVID-19 being prepared simultaneously at Gazipur crematorium on April 26, 2021 in New Delhi, India.

Enlarge / Funeral pyres of people that died of COVID-19 being ready concurrently at Gazipur crematorium on April 26, 2021 in New Delhi, India. (credit score: Getty | Raj Ok Raj)

India’s skyrocketing surge of COVID-19 circumstances has launched the nation into probably the most harrowing disaster but within the pandemic.

Whereas worldwide help pours into the nation, many have referred to as for the US to donate tens of millions of doses from its stockpile of AstraZeneca’s COVID-19 vaccine to India, which has vaccinated lower than 2 % of its inhabitants and is operating out of doses.

AstraZeneca’s vaccine is broadly used all over the world, together with in India, however it isn’t but licensed to be used within the US. Even when it does earn authorization right here, Biden administration officers say it’s unlikely that the US will want the vaccine, given the wholesome amount of provides of the three COVID-19 vaccines already licensed within the nation made by Moderna, Pfizer-BioNTech, and Johnson & Johnson.

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CDC, FDA raise pause of J&J vaccine after advisors vote in help of use [Updated]

Boxes of Johnson & Johnson's Janssen COVID-19 vaccine at a vaccination site in Florida.

Enlarge / Bins of Johnson & Johnson’s Janssen COVID-19 vaccine at a vaccination website in Florida. (credit score: Getty | Paul Hennessy)

Replace 4/23/2021 7:00pm ET: The Facilities for Illness Management and Prevention and the Meals and Drug Administration introduced late Friday that the pause on using Johnson & Johnson’s one-shot COVID-19 vaccine is now lifted.

The announcement comes simply hours after a panel of CDC advisors voted largely in favor of resuming use, reaffirming its suggestion that or not it’s utilized in all adults.

The 2 businesses paused use on April 13 after six girls developed harmful blood clots after receiving the vaccine. Although the CDC confirmed 9 further circumstances in the course of the 11-day pause, the businesses and their advisors decided that the advantages of the vaccine vastly outweigh dangers of the extraordinarily uncommon situation.

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Pause of J&J vaccine was the suitable name, say 88% of polled People

A large streetside sign for a Johnson and Johnson vaccine.

Enlarge / Basic exterior view of the top workplace of Janssen pharmaceutical firm on April 15, 2021 in Leiden, Netherlands. (credit score: Getty | BSR Company)

About 88 p.c of People help the pause of Johnson & Johnson’s COVID-19 vaccine, and the pause did not improve vaccine hesitancy, based on contemporary information from the Axios-Ipsos Coronavirus ballot.

The discovering is more likely to hearten public well being consultants, who’ve confronted criticism and concern that the pause may erode confidence in vaccine security and fortify already high-levels of vaccine hesitancy within the nation.

The Facilities for Illness Management and Prevention, together with the Meals and Drug Administration, beneficial a pause in the usage of the Johnson & Johnson vaccine on April 13 after linking the one-dose vaccine to 6 instances of a uncommon blood-clotting situation, one among which was deadly. The six instances occurred amongst greater than 6.eight million individuals given the vaccine, suggesting that if the blood clots are, in actual fact, a facet impact of the vaccine, they’re a particularly uncommon facet impact.

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Extra J&J troubles: Vaccine manufacturing halted and extra doable clot circumstances

The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson's Covid-19 vaccine, in Baltimore, Maryland, on April 9, 2021.

Enlarge / The Emergent BioSolutions plant, a producing associate for Johnson & Johnson’s Covid-19 vaccine, in Baltimore, Maryland, on April 9, 2021. (credit score: Getty | Saul Loeb)

The US Meals and Drug Administration final week requested Emergent BioSolutions to cease making Johnson & Johnson’s COVID-19 vaccine at its troubled facility in Baltimore, in response to a regulatory submitting Emergent launched Monday.

The FDA had begun an inspection of the contract producer’s facility on April 12 however requested on April 16 that manufacturing be halted “pending completion of the inspection and remediation of any ensuing findings,” the submitting reads. Any vaccine supplies already made on the plant shall be held in quarantine.

The manufacturing halt follows information final month {that a} mishap on the plant led to the spoil of 15 million doses of Johnson & Johnson’s one-shot COVID-19 vaccine. The ruined doses had reportedly been contaminated with substances from AstraZeneca’s COVID-19 vaccine, which was additionally being manufactured on the plant on the time.

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At 38.5% vaccinated, US could also be working low on folks looking forward to a shot

Masked crowds wait in cordoned lines.

Enlarge / Residents put on protecting masks whereas ready to be vaccinated at a West Virginia United Well being System COVID-19 vaccine clinic in Morgantown, West Virginia, on Thursday, March 11, 2021. (credit score: Getty | Bloomberg)

The US logged one other four million or so vaccinations Friday, bringing the overall doses administered within the nation over 200 million on the time of writing. Over 127 million adults—38.5 % of the US inhabitants—have obtained no less than one shot. Over 80 million adults—24 % of the US inhabitants—are actually absolutely vaccinated.

The seven-day rolling common of US vaccinations per day is now round 3.35 million, and the Biden administration is on observe to make its newest objective of 200 million vaccinations inside the first 100 days in workplace.

Even with a present pause in use of Johnson & Johnson’s vaccine, Biden officers count on availability of vaccine to stay sturdy.

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99.992% of absolutely vaccinated individuals have dodged COVID, CDC information reveals

Residents wait in an observation area after receiving Covid-19 vaccines at a vaccination site in Richmond, California on Thursday, April 15, 2021.

Enlarge / Residents wait in an statement space after receiving Covid-19 vaccines at a vaccination web site in Richmond, California on Thursday, April 15, 2021. (credit score: Getty | Bloomberg)

Circumstances of COVID-19 are extraordinarily uncommon amongst people who find themselves absolutely vaccinated, based on a brand new information evaluation by the Facilities for Illness Management and Prevention.

Amongst greater than 75 million absolutely vaccinated individuals within the US, simply round 5,800 individuals reported a “breakthrough” an infection, through which they grew to become contaminated with the pandemic coronavirus regardless of being absolutely vaccinated.

The numbers recommend that breakthroughs happen on the teeny charge of lower than 0.008 p.c of absolutely vaccinated individuals—and that over 99.992 p.c of these vaccinated haven’t contracted a SARS-CoV-2 an infection.

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CDC skilled panel punts on deciding destiny of J&J COVID vaccine

Boxes of Johnson & Johnson's Janssen COVID-19 vaccine at a vaccination site in Florida.

Enlarge / Packing containers of Johnson & Johnson’s Janssen COVID-19 vaccine at a vaccination website in Florida. (credit score: Getty | Paul Hennessy)

An advisory committee for the Facilities for Illness Management and Prevention declined to vote on the destiny of Johnson & Johnson’s COVID-19 vaccine Wednesday, probably leaving in place a pause on the vaccine’s use till the committee reconvenes in seven to 10 days.

The CDC’s Advisory Committee on Immunization Practices, or ACIP, expects that the approaching week or so will present further knowledge and analyses on the vaccine’s potential dangers. Till it has extra data, ACIP opted to offer no new suggestions on using the vaccine.

On the desk, nevertheless, was all the pieces from recommending towards use of the vaccine altogether; recommending that solely sure teams obtain the vaccine, akin to solely males or solely folks over a sure age; or recommending that the pause be lifted and use proceed in all adults as earlier than.

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