Moderna and J&J get approval for booster shots: now 99 million Americans want them

On October 21, the Centers for Disease Control and Prevention (CDC) officially recommended booster vaccinations for many COVID-19 vaccine recipients Moderna and Johnson & Johnson. As a result, up to 99 million Americans are now eligible for additional doses. Writes about it CBS News.

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“These recommendations are another example of our fundamental commitment to protecting as many people as possible from COVID-19. Evidence shows that all three COVID-19 vaccines authorized in the United States are safe, as evidenced by more than 400 million vaccine doses administered so far,” CDC Director Rochelle Walensky said Thursday.

The CDC move followed a hours-long meeting of external consultants to the vaccine agency, who ultimately voted unanimously to recommend the boosters.

In accordance with FDA emergency use approvals, the commission voted to support an additional dose of any COVID-19 vaccine that the FDA has approved for all 15 million adults.

The committee said that, as with Pfizer's COVID-19 vaccine, “high-risk” adults who were first vaccinated with doses of Moderna at least six months ago could receive a third shot with either vaccine. This includes seniors aged 65 and over, as well as those vulnerable to serious cases of COVID-19 or those who are frequently exposed to the virus, depending on where they live or work.

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Hoping to add flexibility to the booster vaccine program, the CDC said it would allow Americans to choose a different brand of vaccine for their booster than the one they were first vaccinated with. Early data shows that so-called heterologous, or mixed, boosting - a common practice for some vaccines - is safe and effective.

Several panelists called for a more "lenient" approach after CDC officials said they initially considered whether to recommend that Americans stick to their original brand of vaccine in most situations.

“As a practicing physician in this field, I see people who are smart enough to read the medical literature, and they seem to be advocating for some of the more robust approaches to booster vaccines. And in the interests of fairness, I would really like to provide more flexibility,” said Dr. Camilla Cotton.

This could solve the logistical problems. Some people have no records of what doses they first received. Therefore, health officials say, they may have problems finding their brand, they will be wary of possible side effects or allergic reactions.

Among them are myocarditis and pericarditis, rare side effects associated with the Pfizer and Moderna vaccines that often require hospitalization but usually resolve with standard treatment. Data presented to the committee suggested the risk may be highest among younger men who received Moderna shots.

Some Johnson & Johnson recipients hope that switching to the Moderna or Pfizer vaccine could provide more protection, although evidence to support this approach remains limited.

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Health authorities, as well as pharmacies and other vaccination organizations, have been preparing for weeks to add Moderna and Johnson & Johnson booster shots to their schedules, in addition to new formulations of Pfizer vaccine, which may soon be approved at a lower dose to vaccinate children.

A spokesperson for the National Association of Pharmacy Chains said the pharmacies are "in close coordination" with the CDC and are ready to begin revaccination of Moderna and Johnson & Johnson following the agency's recommendations. Walgreens said in a statement that they are ready to start re-injections in their stores "tomorrow (October 22)."

As with additional Pfizer doses, new boosters can be administered from the same vials already in stock for the first batch of vaccines. The FDA has said that up to 20 booster doses can be obtained from Moderna vials because the company's booster vaccine is half the size of the first two doses.

After some CDC advisers raised concerns about Moderna's decision to use the same vial for two different dose sizes, the company defended the move, citing the need to deploy booster injections in a "pandemic context."

Dr. Jacqueline Miller of Moderna said the company is still considering packaging changes for the vaccine, especially with the introduction of new doses for young children.

“It won't be easy. This requires updating existing inventory and expense reporting systems. What about inventory-based planning systems? They also need to change,” says Dr Litjen Tan, chief policy officer and partnerships officer at the Immunization Action Coalition.

Tan said many vaccinators already have experience with large multi-dose vials for routine vaccinations, but rarely with other dose sizes, which could increase the risk of errors or contamination.

“We did have a situation at one point where a one-season flu vaccine was approved for pediatric use at half dose, and that took some thought and preparation. We didn’t have any problems then, but it was an unusual case,” Tan emphasized.

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