FDA approves boosters as WHO battles for Moderna vaccine formula

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As the Food and Drug Administration approves booster doses for both the Moderna and Johnson & Johnson COVID-19 vaccines, and the White House readies to get shots into the arms of children, the World Health Organization is fighting an equity battle to get worldwide availability of the vaccine.

The World Health Organization has hired a company called Afrigen Biologics and Vaccines as part of a $100 million plan to figure out how to make a vaccine against COVID-19 that is as close as possible to the version produced by Moderna, according to NPR.

Moderna refuses to share its recipe, with company Chairman Noubar Afeyan telling the AP in Rome that this is because executives have concluded that scaling up the company's own production is the best way to increase the global supply, However, Afeyan reiterated a pledge Moderna made a year ago not to enforce patent infringement on anyone else making a coronavirus vaccine during the pandemic.

Why WHO is going after the Moderna formula, and not that of Pfizer or the Johnson & Johnson vaccine, was a question not immediately answered in a request for comment.

Moderna also did not immediately reply.

WHO has been tweeting comments made by WHO Director General Tedros Adhanom Ghebreyesus.

"The harsh reality of vaccine inequity: the rate of booster doses in high-income countries is approaching the low-income countries primary dose rate. This injustice costs lives and livelihoods and only prolongs the pandemic," WHO posted on Twitter as comments from Tedros. "The barrier is not production. The barriers are politics and profit."

WHO tweeted: "#COVAX (Vaccines Global Access) has the money and contacts to buy #COVID19 vaccines. What we don't have is any visibility on when the manufacturers will deliver" – @DrTedros. "And they must share know-how, technology, licenses and waive intellectual property rights. We're not asking for charity; we're calling for a common-sense investment in the global recovery" – @DrTedros #VaccinEquity.

WHY THIS MATTERS

WHO's fight for global equity in vaccine distribution comes as the U.S. Food and Drug Administration approved booster doses yesterday for both the Moderna and Johnson & Johnson COVID-19 vaccines, but for different eligible populations. 

Moderna has amended emergency use authorizations to give a booster shot at least six months after completion of the primary series to individuals 65 years of age and older; people 18 through 64 who are at high risk of severe COVID-19; and those who have frequent, institutional or occupational exposure to the coronavirus.

A booster dose of the J&J COVID-19 vaccine may be administered at least two months after completion of the single-dose shot to individuals 18 years of age and older.

A booster dose of the Pfizer-BioNTech COVID-19 vaccine has already been approved for administration at least six months after completion of the primary series to individuals 18 through 64 with frequent institutional or occupational exposure to the virus.

The FDA is allowing for mix and match booster shots.

Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research said, "We are also taking action today to include the use of mix and match boosters to address this public health need."

Acting FDA Commissioner Dr. Janet Woodcock said, "The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease."

The Biden administration has released its plan to distribute doses to children at doctors' offices, pharmacies and schools, after federal regulators give the expected approvals for the shots for children ages 5-11.

On Tuesday, the White House said that the start of the vaccination program for children ages 5-11 will depend on the independent FDA and Centers for Disease Control and Prevention timeline. The FDA's advisory committee meets Tuesday, October 26 and the CDC's independent advisory committee meeting is scheduled for November 2-3.

THE LARGER TREND

Rates of hospitalization among children are higher than earlier in the pandemic, due to the highly transmissible Delta variant. Public health authorities plan to offer shots in settings more familiar for children than the mass sites used for many adults, according to The Wall Street Journal.

As of Wednesday, about 8.9 million boosters had been administered, covering 4.7% of all fully vaccinated Americans and more than 12% of the immunized 65 and older population, according to CNBC.

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com