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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. The evidence shows that all three COVID-19 vaccines approved in the US are safe, as evidenced by over 400 million doses of vaccine already, ”said CDC Director Rochelle Walenski on Thursday October 21st.

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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In hopes of adding flexibility to the revaccination program, the CDC said it would allow Americans to choose a brand other than the brand they were first vaccinated with for their booster vaccine. Early evidence suggests that so-called heterologous or blended reinforcement — a common practice with 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 practitioner in the field, I see people who are smart enough to read the medical literature, and they seem to advocate some of the more reliable approaches to booster vaccines. And for the sake of fairness, I would very much 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.

These include myocarditis and pericarditis, rare side effects associated with Pfizer and Moderna vaccines that often require hospitalization but usually resolve with standard treatment. The data presented to the committee suggests that the risk may be highest among young men who receive the Moderna vaccine.

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 waste reporting systems. What about inventory-based planning systems? They also need to be changed, ”said Dr. Litjen Tan, Chief Policy Officer and Partnership Officer for the Coalition for Immunization Action.

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 the one season flu vaccine was approved for pediatric use at a half dose, and it took some thought and preparation. We didn't have any problems then, but it was an unusual thing, ”Tan stressed.

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