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FDA Asks Moderna, Pfizer to Add More Children to COVID-19 Vaccine  Efficacy Studies


FILE - Max Cuevas, 12, holds his mother's hand as he receives the Pfizer COVID-19 vaccine from nurse practitioner Nicole Noche at Families Together of Orange County in Tustin, California, May 13, 2021.

The U.S. Food and Drug Administration has asked Pfizer and Moderna to increase the number of school-age children in their ongoing clinical trials to determine if their COVID-19 vaccines are safe for children under 12 years old.

The two drug makers are currently testing their respective vaccines on children between five and 11 years old to assess their chances of developing rare heart inflammation conditions that have been detected in young people under 30 who received the vaccine. The conditions include myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the lining around the heart.

The request could delay formal approval of the two dose vaccines for children in that age group. Moderna, which enrolled nearly 7,000 children in its initial phase of the trial, says it is “actively discussing” the proposal with the FDA. Pfizer, which has enrolled up to 4,500 children between 6 months to 12 years old, says it expects to have results for the 5-11 age group in September, followed by results for ages 2-5 years old shortly after.

The Biden administration said Monday that it will maintain any existing travel restrictions to the United States due to the rise of the more contagious delta variant of COVID-19. The restrictions on dozens of nations across Europe and other parts of the globe, including China, were first imposed at the start of the pandemic in January 2020. The delta variant has been detected in more than 90 countries and comprises more than 80% of all new COVID-19 infections in the U.S.

The push for mandatory vaccinations among health care workers gained further momentum Monday when New York City announced a requirement for all of its municipal employees, including police officers and teachers, to either receive a COVID-19 vaccine or undergo weekly testing. The state of California also issued a mandatory vaccination order for all of its employees plus millions of public and private health care workers.

COVID-19 patient Brian Parisi from Orange County is treated by staff in the ICU at Providence St Joseph Hospital in Orange, California, July 23, 2021.
COVID-19 patient Brian Parisi from Orange County is treated by staff in the ICU at Providence St Joseph Hospital in Orange, California, July 23, 2021.

The two governments joined the U.S. Veterans Affairs department, which operates 1,700 medical centers and outpatient clinics for retired military personnel, in making vaccinations mandatory for most of its health care workers, becoming the first U.S. federal agency to impose such a demand.

In Australia, authorities in southern Victoria state said Tuesday that it will end a five-day hard lockdown on its 5 million residents imposed to battle a surge of new coronavirus infections due to the delta variant. Victoria state Premier Daniel Andrews said schools, bars and restaurants will be allowed to reopen, although households will not be permitted to welcome visitors.

Australia has been battling a surge of new COVID-19 cases since late June that has been traced to a Sydney airport limousine driver who tested positive for the delta variant after transporting international air crews. Health officials in New South Wales state, of which Sydney is the capital, reported a new single-day record of 172 new infections on Tuesday. Ten people have died during the latest surge.

Patrolling police officers check IDs of people working out at a Bondi Beach outdoor gym area during a lockdown to curb the spread of COVID-19 outbreak in Sydney, Australia, July 27, 2021.
Patrolling police officers check IDs of people working out at a Bondi Beach outdoor gym area during a lockdown to curb the spread of COVID-19 outbreak in Sydney, Australia, July 27, 2021.

Australia has been largely successful in containing the spread of COVID-19 through aggressive lockdown efforts, posting just 33,266 total confirmed cases and 922 deaths, according to the Johns Hopkins Coronavirus Resource Center. But it has proved vulnerable to fresh outbreaks due to a slow rollout of its vaccination campaign, with only 13% of its citizens fully vaccinated.

And Tokyo recorded 2,848 new COVID-19 infections Tuesday, a new single-day record for the host city of the pandemic-delayed Summer Olympics. The Japanese capital is under a fourth state of emergency that will remain in effect until August 22.

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