FDA Removes Targeting Updated Vivid Assists Latest Variants

WASHINGTON – The United States on Wednesday authorized the first update to the COVID-19 vaccine, booster dose targeting the most common omicron strain today. Shooting can begin within a few days.

The move by the Food and Drug Administration to tweak the formula of photos taken by Pfizer and rival Moderna has saved millions of lives. The hope is that the modified boosters will alleviate a winter spike.

“You’ll meet me at the front of the line,” FDA vaccine executive Dr Peter Marks told The Associated Press shortly before his agency announced the new doses.

So far, the COVID-19 vaccine has targeted the original coronavirus strain, even as wildly different mutations emerged. The new US booster is a combination or so-called “dual price” rocket. They contain half the original vaccine formulation and half protection against the latest formulation omicron versionknown as BA.4 and BA.5, are considered the most contagious.

This combination is intended to increase cross protection against multiple variants.

“It really offers the broadest chance of protection,” Annaliesa Anderson, Pfizer’s director of vaccines, told the AP.

Read more: An N95 is the best Mask for Omicron. This is why

The updated boosters are only for people who have had their primary vaccinations, to use original vaccine. Amount made by Pfizer and its partner BioNTech are for anyone 12 years of age or older while Moderna’s updated shots are for adults – if it’s been at least two months since the last primary immunization or booster their latest. They are not used for primary vaccination.

There is one more step before the fall booster campaign begins: The Centers for Disease Control and Prevention must recommend who should get the booster shot. An influential CDC advisory panel will debate the evidence on Thursday – including whether people in high risk from COVID-19 should go ahead.

“As we start to fall and start spending more time indoors, we strongly encourage anyone who is eligible to consider a booster dose of the divalent COVID-19 vaccine to provide relief. better protection against circulating variants,” FDA Commissioner Dr. Robert Califf said in a statement.

The US has purchased more than 170 million doses from these two companies. Pfizer said it could ship 15 million doses of the drug by the end of next week.

The big question is whether people bored with vaccinations will roll up their sleeves again. Only half of vaccinated Americans have recommended first booster doseand only a third of those 50 and older who were asked to get a second booster shot did so.

It’s time for US authorities to make it clearer that the public should expect regular updates on COVID-19 vaccinations, like a fall flu shot or a tetanus shot after stepping on a nail. rust, said immunologist E. John Wherry of the University of Pennsylvania.

“We need to rename it in a socially normal way,” says Wherry, rather than a panic reaction to new mutants. “Put a set of clear, forward-looking expectations.”

Here’s the takeaway: The original vaccines still provide strong protection against severe illness and death from COVID-19 for most generally healthy people, especially if they receive them. That important first booster dose. It’s unclear what more benefit the updated booster would provide – other than a temporary jump in antibodies that are able to fight off omicron infections.

One reason: The FDA removed revisions prior to human studies, a step toward final handling of COVID-19 vaccine updates like annual flu shot.

First, the FDA examined human studies on Pfizer and Moderna before trying to update their vaccines — shots that matched the omicron strain happened last winter. That formulation change was safe and essentially promoted antibodies that targeted the previous variant – better than another dose of the original vaccine – while adding a little protection against present-day genetically distinct omicron versions BA.4 and BA.5.

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But the FDA has ordered companies to make even more up-to-date dosages to target the latest omicron mutations, instead sparking a race to deliver doses in less than a year. three months. Rather than wait a few more months for additional human studies of that formulation tweak, Marks said animal tests show the latest update promotes a “very good immune response.” .

It is hoped that a vaccine that matches the variants that are spreading now can do a better job against infection, not just serious illness, at least for a while, he said. .

What’s next? Even as modified footage rolls out, Moderna and Pfizer are conducting human studies to help gauge their value, including how they hold up should a new mutant emerge.

And for kids, Pfizer plans to ask the FDA for permission to update the boosters for kids ages 5 to 11 as early as October.

This is the first US update to the COVID-19 vaccine formula, an important but expected next step – in the same way that flu vaccines are updated every year.

And the United States is not alone. Britain recently decided to offer adults over 50 another boost option from Moderna, a combo shot that targets that original omicron BA.1 strain. European regulators are considering whether to allow one or both formulas to be updated.

Writer AP Health Matthew Perrone contributed to this report.

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