FDA Panel Endorses Pfizer COVID-19 Shot for Kids

The U.S. Food and Drug Administration’s independent advisory committee endorsed giving child-size emergency doses of the Pfizer-BioNTech COVID-19 vaccine to children ages 5-11.

While it is considered rare for younger children to become seriously ill or die from COVID-19, FDA vaccines chief Dr. Peter Marks told the panel Tuesday that 1.9 million children in the 5 to 11 age group have tested positive and 8,300 have been hospitalized in the United States. Of those hospitalized, one-third needed intensive care, and nearly 100 died.

With the approval of the vaccine for use in children, officials said they hoped it would help close a major gap in the U.S. vaccine campaign that had been worrying parents, educators and public health leaders.

Regulators said shots could begin as soon as next week.

Last week, the White House said it had already obtained enough vaccine for the 28 million children in the United States who would become eligible and established a network of pediatricians, pharmacies and other health care providers to quickly distribute the shots.

The FDA, which isn’t bound by the panel recommendation, will make its decision in the next few days.

Pending FDA approval, the Centers for Disease Control and Prevention’s independent advisory committee is expected to consider the proposal next week.

In a related development, U.S.-based pharmaceutical company Moderna said a clinical trial showed that a low dose of its COVID-19 vaccine was safe for children ages 6 to 11.

The company said it inoculated more than 4,700 children with its two-dose vaccine about 28 days apart, with each shot about half the strength given to adults. Preliminary results show the antibody levels in the children were at same level as those seen in young adults who received a full dose.

Moderna says the children suffered mild side effects such as fatigue, headache, fever and pain at the injection site. The number of test subjects was too small to detect any rare side effects such as myocarditis, an inflammation of the heart, which has been detected mostly among boys and young men who received either the Moderna or the Pfizer vaccine.

The study has not been published by any peer-reviewed journal, but Moderna says it will soon present its findings to the FDA and other global drug regulators.

Meanwhile, the Reuters news agency is reporting that the African Union will purchase up to 110 million doses of the Moderna vaccine. The AU will receive 15 million doses before the end of the year, with another 35 million doses arriving in the first quarter of 2022 and up to 60 million in the second quarter.

The purchase was facilitated by the White House, which is deferring delivery of 33 million doses it had purchased from Moderna to give the AU an opportunity to negotiate with the company.

According to the report, in an email, AU coronavirus envoy Strive Masiyiwa said the deal allowed the alliance to increase the number of vaccines available immediately. He said, “We urge other vaccine producing countries to follow the lead of the (U.S. government) and give us similar access to buy this and other vaccines.”

The CDC has extended the coronavirus health rules for cruise ships until January 15, 2022. The current regulations, which were first imposed in March 2020 and include a requirement for ships to sail with at least 95% of passengers and crew fully vaccinated, were set to expire November 1.

The CDC says when the current regulations expire in January, it will shift to a voluntary program for cruise ship operators to detect and control the spread of COVID-19 on their vessels.

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

Author: Pascal