COVID-19 Booster Shots Reportedly to Start at 6 Months

When the federal government announced recently that COVID-19 booster shots would be made available to some adults 8 months after their last dose, apparently Infection Control Today^® (ICT^®) wasn’t alone in asking why public health officials had decided to draw the line there. As ICT^® put it last Friday: “[H]ow did public health officials decide that boosters should be given at 8 months prior to the last dose? Why not 7? Or 6? Or 5?”

Well, 6 it is, according to the Wall Street Journal, relying on one of the newspaper’s unnamed sources. The newspaper reports that “data from vaccine manufacturers and other countries under review by the Food and Drug Administration is based on boosters being given at 6 months, the [unnamed source] said. The person said approval for boosters for all three COVID-19 shots being administered in the U.S.—those manufactured by Pfizer Inc. and partner BioNTech SE, Moderna Inc. and Johnson & Johnson—is expected in mid-September.”

As ICT^®’s sister publication^, Contagion^®, reports, that announcement was predicated on the decision that a booster shot would be needed because of waning immunity of the vaccines due to the delta variant, which is the predominant variant in the US.

The original statement setting the number at 8 months was released on August 18 and came from some of the most influential leaders in public health care including: Rochelle Walensky, MD, director of the Centers for Disease Control and Prevention (CDC); Janet Woodcock, MD, acting commissioner, Food and Drug Administration (FDA); Vivek Murthy, MD, US Surgeon General; Francis Collins, MD, director of the National Institutes of Health (NIH); and Anthony Fauci, MD, chief medical advisor to President Joe Biden.

The statement: “We are prepared to offer booster shots for all Americans beginning the week of September 20 and starting 8 months after an individual’s second dose. At that time, the individuals who were fully vaccinated earliest in the vaccination rollout, including many health care providers, nursing home residents, and other seniors, will likely be eligible for a booster.”

The fact that US health officials were backing booster shots—a move that had already been backed by health officials in Israel, Germany, the United Kingdom, France, and Russia—made headlines.

“Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout,” the joint statement read. “For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.”

The plan is subject to FDA approval, and Pfizer/BioNTech announced yesterday that it initiated a rolling submission for its COVID-19 vaccine BNT162b2 (Comirnaty) to seek an FDA supplemental Biologics License Application (sBLA) that would allow for marketing and prescribing of a third booster dose of the vaccine for fully vaccinated individuals aged 16 years and older. Moderna announced yesterday that it has submitted its formal BLA with the FDA for its COVID-19 vaccine, mRNA-1273. And Johnson & Johnson announced yesterday positive data supporting a booster dose of their COVID-19 vaccine, Ad26.COV2.S.

The adjustment of the booster shot timetable—if that should come about—comes on the heels of the FDA’s granting full approval to the Pfizer/BioNTech vaccine. The vaccine had been approved under the FDA’s emergency use authorization.

Health care experts have been pushing the FDA to grant full approval to the COVID-19 vaccines as soon as possible as a way of inducing the vaccine hesitant to get inoculated in order to beat back the delta variant.

The booster shots will help older Americans.

Meanwhile, evidence grows that the delta variant (B.1.617) infects younger people much more than the variant that had been dominant this time last year, the so called wild-type variant (D614G).

Linda Spaulding RN, BC, CIC, CHEC, CHOP, is a member of ICT^®’s Editorial Advisory Board. In an article to be published in an upcoming print edition, Spaulding writes that “once again, the United States is dealing with a surge of the delta variant of COVID-19 with health care facility beds filling up with not solely the elderly, but with kids as young as 11-days-old and people in their 50s. They are unvaccinated.” (Spaulding’s coauthor of the article is Connie Henry, BSN, RNC.) The CDC says that 51.1% of the US adult population has been fully vaccinated.

There are still no COVID-19 vaccines for children 5–12, although Fauci said this week that it’s possible that one might become available by late fall, but tempered that prediction by adding that there will be many variables in play for such a vaccine to become reality. “I’m talking about the data that will be presented to the FDA,” Fauci told NPR. “The decision about the relative risk benefit of safety and efficacy is going to be a regulatory decision. So even though I’m telling you that the data will be available at the time we get to mid and late fall, it may be that when the FDA looks at the data, they may feel they want a little bit more time for safety.”

In a separate interview, Collins told NPR that any vaccine for that age group will not be available until late this year, at the earliest. “I got to be honest, I don’t see approval for kids 5 to 11 coming much before the end of 2021,” Collins said.

Meanwhile, the data seem to back up what Spaulding’s seeing: A surge in COVID-19 infections among children. For the week ending August 19, more than 180,175 COVID-19 cases were reported in children, according to the American Academy of Pediatrics. At the end of July, it was about 38,000 children per week being infected.