The US approved its first update to its COVID-19 vaccine on Wednesday. A booster dose that targets today’s most common Omicron strains. Shots could start in a few days.
The FDA’s move tweaks recipes for shots made by Pfizer and rival Moderna that have already saved millions of lives. Improved boosters blunt yet another winter surge It is expected that
“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.
For Canada, Moderna announced last week that it would supply 12 million doses of COVID-19 shots adapted to target the Omicron subspecies of the coronavirus.
A Health Canada spokesperson said on August 22 that a decision on Moderna’s bivalent vaccine is expected within the next two weeks.
“The Widest Opportunity for Protection”
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. They contain 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 really provides the broadest 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.
Whereas the dose created by Pfizer and its partner BioNTech is intended for people aged 12 and over, Moderna’s updated shot requires at least two months have passed since the last primary vaccination or most recent booster. If so, it is intended for an adult audience. Not for 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 the evidence 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 people over the age of 50 who were urged to get the booster dose 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. .
Rather than a panic reaction to the new mutants, Welley said, “We need to rebrand them in ways that appear socially normal. Give them a clear and positive set of expectations.”
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 boosters will provide beyond a temporary increase in antibodies that can fend off Omicron infection.
One reason is that the FDA allowed changes prior to human studies. This is a step towards finally treating his COVID-19 vaccine renewal like an annual flu shot.
WATCH | Health Canada poised to approve new Omicron-targeted vaccine
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.
Pfizer also plans to ask the FDA to allow its newest booster for children 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.