FDA Authorizes Updated COVID-19 Vaccines Targeting Omicron Subvariant

August 31, 2022 by Dan McCue
FDA Authorizes Updated COVID-19 Vaccines Targeting Omicron Subvariant
This August 2022 photo provided by Pfizer shows vials of the company's updated COVID-19 vaccine during production in Kalamazoo, Mich. (Pfizer via AP)

WASHINGTON — The Food and Drug Administration on Wednesday authorized updated COVID-19 booster shots specifically targeting a subvariant of omicron.

The agency approved two options aimed at the BA.5 subvariant of omicron that is now dominant in the U.S.: one made by Pfizer and its German partner BioNTech for use in people as young as 12; the other, manufactured by Moderna, for those 18 and older.

Wednesday’s authorization allows the use of the new bivalent formulations of the vaccines as a single booster dose at least two months following primary or booster vaccination.

 Both represent the first major redesign of the COVID vaccines since they were initially injected into arms in December 2020.

The updated boosters include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron subvariants BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant. 

The BA.4 and BA.5 lineages of the omicron variant are currently causing most cases of COVID-19 in the U.S. and are predicted to circulate this fall and winter. 

The doses can be given at least two months after people last received a booster dose or completed their initial series of vaccinations.

“As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose,” Dr. Robert M. Califf, the F.D.A. commissioner, said in a written statement. 

He added that the newly formulated vaccine would “provide better protection against currently circulating variants.”

But the approval of the new vaccines didn’t come without some push back from members of the FDA advisory committee that reviewed their efficacy.

The concern mainly revolves around the speed at which the new vaccines were turned around — the FDA advised the companies only two months ago on the formulation that they should adopt for the new vaccines — and the resulting lack of human trials.

Both Pfizer and Moderna went to federal regulators this summer with more limited data on the redesigned boosters than a traditional review process would call for — instead of human trials, they presented the outcome of tests of the new vaccines on mice.

Last week, Dr. Paul Offit, a member of the FDA advisory committee, told The Well News he was, at best, skeptical of the data the pharmaceutical companies have presented. 

“As a famous vaccinologist at the Wistar Institute says: ‘Mice lie and monkeys exaggerate,’” he said, referring to the independent, nonprofit research institution in Philadelphia.

“You can’t use mice to predict events in people. You just can’t,” Offit said. “I mean, let me put it this way, if mouse studies were predictive of outcomes in people, we would have had an AIDS vaccine 30 years ago.

“The bottom line is, mice aren’t people. They have a different genome … and while they help sort of point you in the right direction … I just don’t think tests on mice can be used as a proof that something is going to be valuable that you’re about to give to millions of people. I just don’t think that’s adequate. And I think that the American public deserves more data than what we’ve been given,” he said.

But others argue that because the coronavirus is evolving so quickly, human trials would be out of date long before a formal authorization could be handed down.

According to the Centers for Disease Control and Prevention, the number of COVID cases, deaths and hospitalizations are all trending lower.

As of Wednesday morning, the daily average of new cases wass 82,475, with the average daily number of deaths being 387, and the average daily new admissions to hospitals being 5,255.

Vaccinations continue to be at the heart of the Biden administration’s COVID response strategy. 

The White House has already ordered over 170 million doses of the new vaccine for a fall booster campaign, and, now that the FDA has weighed in, expects those boosters to reach the states in a matter of days.

Dan can be reached at [email protected] and at https://twitter.com/DanMcCue.

A+
a-
  • booster shots
  • COVID-19
  • Food and Drug Administration
  • omicron
  • variants
  • In The News

    Health

    Voting

    Health

    April 25, 2025
    by Dan McCue
    Kennedy Unveils Plan to Expand Access to Sickle Cell Treatment

    CHARLESTON, S.C. — Health Secretary Robert F. Kennedy Jr. used a morning keynote address before a group of state lawmakers... Read More

    CHARLESTON, S.C. — Health Secretary Robert F. Kennedy Jr. used a morning keynote address before a group of state lawmakers in Charleston, South Carolina, to unveil a new initiative intended to expand access to the latest treatments for sickle cell disease. Kennedy offered few details in... Read More

    Whooping Cough Cases Rising Again in the US

    Whooping cough cases are rising, and doctors are bracing for yet another tough year. There have been 8,485 cases reported in... Read More

    Whooping cough cases are rising, and doctors are bracing for yet another tough year. There have been 8,485 cases reported in 2025, according to preliminary data from the U.S. Centers for Disease Control and Prevention. That’s twice as many cases as this time last year, based on the... Read More

    Bluebells and Other Spring Flowers Can Be Nature's Antidote to Stressful Times

    HALLE, Belgium (AP) — Gilles Gui was looking for the magical purple bluebells that raise their heads each spring under... Read More

    HALLE, Belgium (AP) — Gilles Gui was looking for the magical purple bluebells that raise their heads each spring under the budding beech leaves of the Hallerbos forest, an annual explosion of color that draws crowds from around the world. And in these times full of stress... Read More

    EPA Chief Demands That Mexico Stop Tijuana Sewage From Flowing Into California

    SAN DIEGO (AP) — The head of the Environmental Protection Agency said Tuesday that Mexico must stop the flow of billions of... Read More

    SAN DIEGO (AP) — The head of the Environmental Protection Agency said Tuesday that Mexico must stop the flow of billions of gallons of sewage and toxic chemicals from Tijuana that has polluted the Pacific Ocean off neighboring Southern California, closing beaches and sickening Navy SEALs who train... Read More

    April 22, 2025
    by Dan McCue
    FDA to Phase Out Petroleum-Based Dyes in Foods

    WASHINGTON — The Food and Drug Administration announced Tuesday that it plans to end the use of petroleum-based synthetic food... Read More

    WASHINGTON — The Food and Drug Administration announced Tuesday that it plans to end the use of petroleum-based synthetic food dyes in America’s food supply within the next two years in a bid to combat a myriad of health concerns, especially among children. The policy was... Read More

    Advanced Cancers Returned to Prepandemic Levels, According to Report

    Many Americans were forced to postpone cancer screenings — colonoscopies, mammograms and lung scans — for several months in 2020 as COVID-19... Read More

    Many Americans were forced to postpone cancer screenings — colonoscopies, mammograms and lung scans — for several months in 2020 as COVID-19 overwhelmed doctors and hospitals. But that delay in screening isn't making a huge impact on cancer statistics, at least none that can be seen yet by... Read More

    News From The Well
    scroll top