CDC approves updated Covid-19 booster

0
4


The CDC’s Advisory Committee on Immunization Practices voted 13-1 earlier in the day to recommend an updated mRNA booster to Americans this fall.

Walensky’s decision means those vaccines could be available on Friday, according to the drugmaker. They started shipping the new dose after the FDA approved it on Wednesday.

“Updated COVID-19 boosters are designed to better protect against the latest circulating COVID-19 variants,” Walensky said in a statement. “They could help restore protection that has weakened since the last vaccination, and aims to provide broader protection against new variants. This recommendation follows a thorough scientific assessment and extensive scientific discussion. If you are eligible, it is a good time to get your COVID-19 alert, I strongly It is recommended that you get it. »

The updated booster has instructions telling our cells to make antibodies against the two strains of the virus that cause Covid-19: the original strain and the BA.4 and BA.5 Omicron sub-variants, which have the same peak.

Pfizer/BioNTech’s updated vaccine is a 30-microgram dose licensed for use in people 12 years of age and older. Moderna’s updated vaccine is an authorized dose of 50 micrograms for people 18 and older.

The CDC said in the statement that it “also plans to recommend updated COVID-19 boosters for other pediatric groups in the coming weeks.”

As long as people complete all primary doses of the vaccine series, they are eligible for the newer boosters. The committee recommends that new boosters be given at least two months after the last dose of Covid-19 vaccine and three months after infection.

The new formulation will not replace the main line of injectables.

The boosters were approved based on studies in mice with the human ACE-2 receptor, the gate that coronaviruses use to enter our cells, but clinical trial data showing their effect in humans will be another month or two before get.

This is similar to how the flu vaccine is researched and approved every year, but this is a first for a Covid-19 vaccine.

In approving the vaccine, regulators also looked at the data behind the different two strains of boosters. These come with instructions for fighting the original strain of Omicron variant BA.1 as well as the original virus. These reminders have been studied in about 1,400 people. They are approved for use in the UK and Canada, but not in the US.

Several committee members said Thursday they were reluctant to recommend a vaccine without support from human data.

“We’re extrapolating the data we’ve seen with bivalent BA.1, and hopefully we’ll get similar data for BA.4 and BA.5,” said Ohio State University pediatrician Pablo Sanchez, Ph.D. and a committee member.

Moderna CEO says Covid vaccine will develop like 'iPhone'

“So I’m just concerned with that extrapolation. And because at the end of the day, I really don’t want to set a precedent by recommending a vaccine for which we don’t have clinical data,” said Sanchez, who voted against the recommendation.

That drew a swift rebuttal from government experts working with the committee.

“I just want to remind the committee that we use a new strain-based flu vaccine every year without conducting any clinical studies,” said Dr. Melinda Wharton, deputy director of vaccine policy at the National Center for Immunization, CDC. disease.

“I appreciate the level of discomfort I’ve heard from committee members who are being asked to make the leap on a Covid vaccine that they haven’t been asked to do before with a Covid vaccine,” said Dr. Doran Fink, deputy director of the FDA’s Division of Vaccine and Related Product Applications .

“The FDA is very comfortable with the way it extrapolates safety and efficacy or known and potential benefit,” Fink said. “We recognise that we have taken a different path than European and Canadian regulators. »

Fink said the U.S. chose this path based on feedback from its independent advisory panel and projections about the potential spread of the virus in the country during the fall and winter.

Under 60, healthy, vaccinated and boosted?  "you are in a good place"  with Covid-19

On Thursday, the committee saw new modelling data that indicated significant risks in deploying the new booster.

The booster given to U.S. adults in September could avoid more than 137,000 hospitalizations and 9,700 deaths, compared with a booster given before November, according to the CDC.

A new analysis of the cost-effectiveness of boosters suggests the U.S. could save at least $63 billion in medical care between August and March 31 if as many people received these boosters as the flu vaccine in 2021-22. Fee season.

In studies examining targeted injections of BA.1 with the original vaccine, the boosters expanded immunity to many variants, and they were found to be better than older single-strain boosters because they produced higher levels of antibodies.

Moderna has provided tantalizing data that its two-strain vaccine against the beta variant can extend the protection people get from the vaccine, which is currently declining significantly after about four months. A study of the findings is being prepared for publication, he said.

In mice with human ACE-2 receptors, the two-strain vaccine against BA.4 and BA.5 protects against lung infection better than the original vaccine.

According to the CDC, roughly two-thirds of the total U.S. population has received the first round of the Covid-19 vaccine. But less than half of them – less than a third of the population – also received boosters.

CNN’s Naomi Thomas and Deidre McPhillips contributed to this report.



Source link

LEAVE A REPLY

Please enter your comment!
Please enter your name here