FDA Considers Pfizer’s COVID-19 Vaccine for Children

An independent advisory committee of the US Food and Drug Administration (FDA) met Tuesday (26/10) to consider approving emergency use of Pfizer-BioNTech’s COVID-19 vaccine for children ages 5-11. Although children are thought to rarely get seriously ill or die from COVID-19, the FDA’s head of vaccines Dr. Peter Marks Tuesday told the panel that 1.9 million children in America in the age group 5 to 11 have tested positive and 8,300 have been hospitalized. Of those treated, 35% required intensive care and nearly 100 died.

If doses of children’s vaccines are approved as expected, officials say they hope it will help close a huge gap in America’s vaccine campaign that has worried parents, educators and public health leaders.

Last week, the White House said it had obtained enough vaccine to qualify all 28 million American children, and set up a network of pediatricians, pharmacies, and other health care providers to quickly distribute the injections.

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

In a related development, US-based pharmaceutical company Moderna said clinical trials showed that low doses of their COVID-19 vaccine were safe for children between the ages of 6 and 11. The company has inoculated more than 4,700 children with two doses of the vaccine, about 28 days apart, and each injection is about half the amount of vaccine for adults. Preliminary results show antibody levels in children are at levels similar to those seen in young adults who receive the full dose.

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

The purchase was facilitated by the White House delaying delivery of the 33 million doses it had purchased from Moderna to give the African Union a chance to negotiate with the company.

The CDC is extending coronavirus-related health rules for cruise ships until January 15, 2022. The current regulations, which went into effect in March 2020 and include a requirement for ships to sail with at least 95 percent of passengers and crew fully vaccinated, will expire on November 1. The CDC said once it expires in January, the regulation will shift to a voluntary program for cruise ship operators to detect and control the spread of COVID-19 on their ships. [ka/jm]

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