Guidance on boosters has been confusing from the beginning of the discussion. In June, the CDC’s ACIP (Advisory Committee on Immunization Practices) stated there wasn’t enough evidence to support the need for Pfizer and Moderna boosters, even as the companies had reported they were preparing for them this fall. In reality, Pfizer had already been discussing boosters and an update on finances of the vaccines with its investors as far back as February.
In August, Joe Biden called for universal boosters for all American’s to be available in mid-September. In early September, the rift between the FDA and the White House became apparent with the race ahead of protocol with Biden’s announcement coming before the FDA’s meeting to determine the approval of Pfizer as the first shot available for boosters. The FDA’s director of the Office of Vaccines Research and Reviews and her deputy director both announced they’d be stepping down in the coming months.
As recently as mid-September the FDA VRBPAC voted against the use of Pfizer’s boosters in a 16-2 vote citing not enough data, only to be overturned by the CDC days later who opened the boosters to all Americans who qualified:
COVID-19 Vaccine booster shots are available for the following Pfizer-BioNTech vaccine recipients who completed their initial series at least 6 months ago and are:
- 65 years and older
- Age 18+ who live in long-term care settings
- Age 18+ who have underlying medical conditions
- Age 18+ who work in high-risk settings
- Age 18+ who live in high-risk settings1
Mix and Match
Last week, the CDC and FDA authorized the boosters for J&J and Moderna. The Moderna booster will be a half-dose of the initial 2-dose regimen.
Now that all three vaccines available in the U.S. are under EUA for boosters, the thought has recently shifted to the option to mix and match different brands of the vaccines. For those who got the J&J, it’s encouraged to switch over and get an mRNA vaccine from either Moderna or Pfizer, but any brand can be acquired two months after their initial dose.
In June, The NIH announced Phase 1 of a 2 Phase had begun to determine the safety and efficacy of mix and match vaccines. The data is to be submitted sometime next year after follow-up with recipients concludes:
All trial participants will be followed for one year after receiving their last vaccination as part of the study. They will be asked to complete telephone check-ins and various in-person follow up visits. Trial investigators will evaluate participants for safety and any side effects post-vaccination.2
Next Stop: 4th Dose
Today it was announced that some immunocompromised Americans could be eligible for their fourth shot, just six months following their third. This population includes those patients who take steroids or other drugs to support an organ transplant, untreated HIV patients, and some cancer patients.3
The fourth could be any one of the three vaccines available, however those who initially received the J&J should not get a third or fourth dose of any kind. A Moderna booster should be a half-dose.
Will the Fully Vaccinated Please Stand-Up?
Just as the confusion over who is eligible for a vaccine heats up, so does the definition of “fully vaccinated.” Last week, Rochelle Walensky, director of the Centers for Disease Control and Prevention, said the U.S. “may need to update” the definition used for “fully vaccinated.” It seems the hold off on changing the definition is due to the fact that not everyone in the US is eligible for a booster.3
At this time, the CDC defines “fully vaccinated” as:
“persons are those who are ≥14 days post-completion of the primary series of an FDA-authorized COVID-19 vaccine.” It was suggested that the definition will likely need to change in time.3
To be considered fully vaccinated in Israel people must meet one of the following criteria: be 12 or older and have received a booster shot at least a week ago; be within six months of having received a second vaccination shot; or be within six months of having tested positive for Covid-19.5
The “Green Pass” or Covid passport will be turned off for those who aren’t considered fully vaccinated.