Credit ACIP/CDC
#17,669
As expected, yesterday the FDA released a statement on their authorization of both the updated Moderna and Pfizer-BioNTech mRNA COVID shots. A decision on an adjuvanted cell-based vaccine from Novavax is still under review.
Today (Sept 12th) the CDC's vaccine advisory group (ACIP) will convene, and vote on exactly who should be offered this fall's vaccine.
While these new vaccines are based on the XBB.1.5 variant which was dominant last May - and has since been overrun by a plethora of more `biologically fit' variants - it is still expected to be effective in reducing serious illness and death from currently circulating variants.
As with the yearly flu vaccine - how effective, and for how long - is something we won't know until it has been deployed and monitored for several months.
Highlights from the FDA's announcement follow, after which I'll have a postscript:
For Immediate Release:September 11, 2023
Today, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.
What You Need to Know
- Individuals 5 years of age and older regardless of previous vaccination are eligible to receive a single dose of an updated mRNA COVID-19 vaccine at least 2 months since the last dose of any COVID-19 vaccine.
- Individuals 6 months through 4 years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of an updated mRNA COVID-19 vaccine (timing and number of doses to administer depends on the previous COVID-19 vaccine received).
- Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated authorized Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated authorized Moderna COVID-19 Vaccine.
- The FDA is confident in the safety and effectiveness of these updated vaccines and the agency’s benefit-risk assessment demonstrates that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks.
- Individuals who receive an updated mRNA COVID-19 vaccine may experience similar side effects as those reported by individuals who previously received mRNA COVID-19 vaccines as described in the respective prescribing information or fact sheets.
- The updated vaccines are expected to provide good protection against COVID-19 from the currently circulating variants. Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine.
- The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet tomorrow (Sept. 12), to discuss clinical recommendations on who should receive an updated vaccine, as well as further considerations for specific populations such as immunocompromised and older individuals.
- Manufacturers have publicly announced that the updated vaccines would be ready this fall, and the FDA anticipates that the updated vaccines will be available in the near future.
“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
The updated mRNA vaccines are each approved for individuals 12 years of age and older and are authorized under emergency use for individuals 6 months through 11 years of age. As part of today’s actions, the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
Uptake of last fall's COVID BA.5 booster shot was underwhelming (see chart below), with only 17% of eligible Americans getting the shot. Even among those over 65, less than 44% opted for the jab.
While nearly 70% of eligible Americans have completed the primary series, and over 80% have had at least one dose, those shots were formulated on the original strain and any residual protection is likely small.
Many, however, have also experienced one or more bouts of COVID, which should help boost immunity. Once again - how much, and for how long - is the $64 question.
Between aggressive and highly misleading vaccine disinformation on social media, and understandable pandemic fatigue, a lot of people are vaccine hesitant. Whether this vaccination round will fare better than the last one remains to be seen.
As for myself - given my age - I'll be rolling up my sleeve for both the flu and COVID vaccines in the next couple of weeks.
As always, I'll do so with limited expectations. Neither vaccine guarantees I won't be infected, they only reduce the chances, but both should lower my risks of severe illness, hospitalization, or death. At least for a few months.
Being a `belt and suspenders' type guy, I'll also be wearing a face mask in public, avoiding crowds, and obsessively using hand sanitizer.
What might be a minor illness in a 30 year-old can quickly turn into a different ordeal when you are pushing 70. Of course, not everyone will come to the same risk-reward conclusions.
But at least you'll have the option of getting the vaccine if you want it.
