Headquarters of the U.S. Food and Drug Administration (FDA) in Silver Spring, Maryland, November 4, 2019.File photo / Reuters
WASHINGTON: The US approved the first renewal of its COVID-19 vaccine on Wednesday. This is a booster dose that targets the most common Omicron strains today. Shots could start in a few days.
The FDA’s move tweaks recipes for shots that Pfizer and rival Moderna have already saved millions of lives. I’m here.
“You’ll see me on the front lines,” Dr. Peter Marks, the FDA’s vaccine chief, told The Associated Press shortly before his agency authorized the new dose.
So far, COVID-19 vaccines have targeted the original coronavirus strain, but very different variants have emerged. The new US booster is a combination, or “bivalent” shot. It contains half the original vaccine recipe and half protection against the latest Omicron versions called BA.4 and BA.5, which are considered the most contagious to date.
This combination is intended to enhance cross-protection against multiple variants.
“This offers the widest opportunity for protection,” Annalisa Anderson, vaccine director at Pfizer, told The Associated Press.
The updated booster is only intended for people who have already had their primary vaccination, using the original vaccine. While the dose produced by Pfizer and its partner BioNTech is for those over the age of 12, Moderna’s updated shot is for adults – at least two or more since the last primary or most recent booster. If the month has passed, it cannot be used for the first vaccination.
There is one more step before the fall booster campaign kicks off. The Centers for Disease Control and Prevention should recommend who should get additional shots. An influential CDC advisory panel will discuss evidence on Thursday, including whether those at higher risk of COVID-19 should go first.
“As we head into the fall and start spending more time indoors, we are eligible to consider receiving a booster dose with the bivalent COVID-19 vaccine to provide better protection against the currently circulating variant. I highly recommend it to everyone,” said FDA Commissioner Dr. Robert Calif. said in a statement.
The US has purchased over 170 million doses from two companies. Pfizer said it could ship up to 15 million doses by the end of next week.
The big question is whether those sick of vaccinations will roll up their sleeves again. Only one-third of those over 50 who were prompted to take a booster did so.
Immunologist E. John Werry of the University of Pennsylvania says vaccination for COVID-19 is similar to getting a flu shot in the fall or a tetanus booster after stepping on a rusty nail. It says it’s time for U.S. officials to better explain the need for regular updates. .
“We need to rebrand new mutants in a socially normal way, not a panicked reaction. Give clear and positive expectations,” Welley said.
Here’s the problem: The original vaccine offers strong protection against severe illness and death from COVID-19 for most generally healthy people, especially if they receive a critical first booster dose. It’s not clear how much benefit the updated booster will provide beyond a temporary increase in antibodies capable of fending off Omicron infection.
One reason is that the FDA approved the change prior to human studies. This is a step towards finally treating the COVID-19 vaccine update like an annual flu shot.
First, the FDA checked human studies of early attempts by Pfizer and Moderna to update vaccines. That recipe change was safe, greatly boosted antibodies targeting previous variants, and outperformed another dose of the original vaccine, but today’s genetically distinct BA.4 and BA Added a bit of protection against the Omicron version of .5.
But the FDA instead ordered companies to manufacture even more modern doses targeting these latest Omicron variants, sparking a race to roll out shots within three months. Rather than wait a few more months for additional human studies on tweaking that recipe, Marks said animal testing showed the latest update to spur “very good immune responses.”
The hope is that a vaccine adapted to the currently circulating subspecies may, at least for some time, do a better job of fighting not just serious illnesses, but infectious diseases.
what’s next? Moderna and Pfizer are conducting human studies to assess its value, including how it will hold up if new variants emerge.
And for children, Pfizer plans to ask the FDA to allow its newest booster for ages 5 to 11 in early October.
This is the first update in the United States to the COVID-19 vaccine recipe and is an important but expected next step, just as flu vaccines are updated annually.
And it’s not just the United States. The UK recently decided to offer adults over 50 a different booster option than Moderna. This is the first combo shot targeting his BA.1 Omicron strain. European regulators are considering whether to approve one or both of the updated formulas.