FDA Delayed Pfizer Shot for Children Because it Didn’t Work Well Against Omicron

The Wall Street Journal Friday, citing sources close to the decision, reported the U.S. Food and Drug Administration (FDA) last week delayed its review of the Pfizer-BioNTech COVID-19 vaccine for under-5-year-olds because initial testing showed its two-dose series was not working well against the omicron variant.

The sources told the Journal early data showed the vaccine to be effective against the delta variant during testing, while that was the dominant strain, but some vaccinated children developed COVID-19 after omicron emerged.

The report quotes the sources as saying so few study subjects, whether vaccinated or unvaccinated, developed the disease during testing so far, that the sample size of omicron cases made the vaccine appear less effective in an early statistical analysis.

The Journal sources said FDA officials think the Pfizer-BioNTech shot might wind up providing stronger protection against omicron once more cases emerge, if the bulk of infections are in unvaccinated subjects. So both the FDA and Pfizer agreed it would be better to wait for additional cases, with the extra time allowing the agency to assess the vaccine’s effectiveness as either a two-dose or three-dose regimen.

The FDA was going to make its decision by looking at whether the shot generated immune responses comparable to those seen in older people. The agency was originally scheduled to assess the shot for children 6 months through 4 years of age on February 15.

In Hong Kong

Meanwhile, in Hong Kong Friday, the city’s chief executive, Carrie Lam, announced elections for its next leader will be postponed for six weeks, as the city grapples with a worsening coronavirus outbreak with thousands of daily infections.

At a news conference, Lam said the vote, scheduled for March 27, would be moved to May 8, because holding the elections sooner could pose “public health risks,” even if a committee of only 1,462 voters were involved. She said the city “is currently facing the most serious pandemic situation since the past two years. The situation is critical.”

Lam also said the city is considering mandatory testing of “everyone in Hong Kong” but added that did not necessarily mean that the city would be put under strict lockdown.

She pointed to cities like Macao, which has tested its entire population twice for the coronavirus.

Health authorities said Thursday that the city’s hospitals were at 90% capacity and that its isolation facilities were full.

In Africa

Egypt, Kenya, Nigeria, Senegal, South Africa and Tunisia are the first African countries to receive technology needed to produce mRNA vaccines from the World Health Organization. Two of the vaccines used in the fight against COVID-19 are mRNA vaccines.

WHO Director-General Dr. Tedros Adhanom Ghebreyesus announced the award Friday in Brussels at the European Union-African Union summit.

“No other event like the COVID-19 pandemic has shown that reliance on a few companies to supply global public goods is limiting, and dangerous,” Tedros said. “In the mid- to long-term, the best way to address health emergencies and reach universal health coverage is to significantly increase the capacity of all regions to manufacture the health products they need, with equitable access as their primary endpoint.”

More than 80% of the population of the African continent has yet to receive a single dose of the COVID-19 vaccine. “Much of this inequity has been driven by the fact that globally, vaccine production is concentrated in a few mostly high-income countries,” Tedros said.

Meanwhile, The Washington Post reports that it has received a document that says the Biden administration will “surge” more than $250 million to 11 African countries for coronavirus vaccine campaigns. The countries slated to receive the “intensive support” are Angola, Ivory Coast, Eswatini – formerly known as Swaziland – Ghana, Lesotho, Nigeria, Senegal, South Africa, Tanzania, Uganda and Zambia.

The Johns Hopkins Coronavirus Resource Center reported early Friday that it has recorded more than 420 million global COVID-19 cases and 5.8 million deaths. The center said 10.3 billion vaccine doses have been administered.

Some information for this report came from The Associated Press and Reuters.

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