The last few months have been a whirlwind of vaccine recommendations, boosters, mandates, and questionable approvals. On Monday, the FDA authorized use of the Pfizer inoculation as a booster for 12-15-year-olds. The agency simultaneously shortened the time between the two-dose primary series and the booster from six months to five. All of this was done without the reconvening of the VRBPAC (Vaccine and Related Biological Products Advisory Committee). In September, the committee voted to restrict boosters for those 65 years and over and those at risk of severe illness. At the time, the committee cited lack of evidence in the risk/benefit of the booster in younger individuals. In September, committee member, Paul Offit, who is also the director of the Vaccine Education Center at Children’s Hospital of Philadelphia stated:
“We’re being asked to approve this as a three-dose vaccine for people 16 years of age and older, without any clear evidence if the third dose for a younger person when compared to an elderly person is of value.”
Signals of discord were evident within the FDA when Marion Gruber, director of the FDA’s Office of Vaccines Research and Reviews, and her deputy director, Phil Krause, announced they’d step down. The announcement came just after Joe Biden publicly announced the push for boosters for all Americans to be available mid-September before any committee meetings. Now approval for the boosters was granted without consulting the advisory board.
Dr. Marty Makary, chief of the Johns Hopkins Islet Transplant Center took aim on Twitter this past Saturday ahead of the announcement of the approval:
Dear President Biden,
FDA is bypassing it’s scientific advisors to authorize boosters for all kids 12-15 next week. This is unconscionable–undermines the integrity of the FDA’s standard process! Please require FDA to put this authoriz before the VRBPAC advisory comm for a vote!
He followed up with:
It is a slap in the face to science for @US_FDA to circumvent the standard convening of the expert advisory board… FDA is quietly doing this because their experts previously voted it down, voicing concerns about medical harms. @POTUS @DrWoodcockFDA
CDC Follows Up with Booster Recommendation
On Tuesday, January 4, the CDC announced:
Today, CDC is updating our recommendation for when many people can receive a booster shot, shortening the interval from 6 months to 5 months for people who received the Pfizer-BioNTech COVID-19 Vaccine. This means that people can now receive an mRNA booster shot 5 months after completing their Pfizer-BioNTech primary series. The booster interval recommendation for people who received the J&J vaccine (2 months) or the Moderna vaccine (6 months), has not changed.
Additionally, consistent with our prior recommendation for adults, CDC is recommending that moderately or severely immunocompromised 5–11-year-olds receive an additional primary dose of vaccine 28 days after their second shot. At this time, only the Pfizer-BioNTech COVID-19 vaccine is authorized and recommended for children aged 5-11.
CDC Director, Rochelle Walnesky, issued the statement:
If you or your children are eligible for a third dose or a booster, please go out and get one as soon as you can. Additionally, FDA took action this week to authorize boosters for 12-15 year olds – and I look forward to ACIP meeting on Wednesday to discuss this issue.
The ACIP (Advisory Committee on Immunization Practices) is set to meet on Wednesday, following the recommendation. Typically, the ACIP recommendation comes as an advisory statement before the CDC’s official recommendation.
Here Comes Omicron, Vaccinated, Booster, or Not
The FDA and CDC cite the increase in COVID cases during the omicron surge as a driving force for the vaccine boosters. Omicron has shown it’s no respecter of vaccine status.
In the December 17, 2021 Morbidity and Mortality Weekly Report, the case for the vaccinated and omicron seemed bleak:
Among these cases of COVID-19 attributed to the Omicron variant, 34 (79%) occurred in persons who completed the primary series of an FDA-authorized or approved COVID-19 vaccine ≥14 days before symptom onset or receipt of a positive SARS-CoV-2 test result, including 14 who had received an additional or booster dose; five of the 14 persons had received the additional dose <14 days before symptom onset. Six (14%) persons had a documented previous SARS-CoV-2 infection. The most commonly reported symptoms were cough, fatigue, and congestion or runny nose. One vaccinated patient was hospitalized for 2 days, and no deaths have been reported to date.
Just a few weeks ago, Pfizer announced it had been developing a new omicron specific vaccine.
The good news is that the omicron peak has seemed to already have passed in just over a month in South Africa with fewer severe cases.