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US Approves Pfizer COVID-19 Vaccine for Children as Young as 12

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FILE - A teacher calls names for schoolchildren to collect a swab and test themselves for COVID-19 to prevent the spread of the coronavirus disease (COVID-19) in the classroom at South Boston Catholic Academy in Boston, Massachusetts, Jan. 28, 2021.

U.S. regulators have authorized the COVID-19 vaccine developed by Pfizer-BioNTech to be used by children as young as 12 years of age, widening the pool of those eligible to get inoculated.

The U.S. Food and Drug Administration said Monday the shot is safe and effective for children ages 12 to 15. The vaccine is already available under an emergency use authorization to those 16 and older.

"Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic," Acting FDA Commissioner Janet Woodcock said in a statement.

The Pfizer vaccine is the first in the United States to be approved for younger people. The approval comes as U.S. officials are seeking to inoculate a larger percentage of the population and will likely prompt millions of U.S. middle and high school students to try to be vaccinated before they head back to class in the fall.

FILE - A person walks past the Pfizer building in Manhattan, New York City, March 2, 2021.
FILE - A person walks past the Pfizer building in Manhattan, New York City, March 2, 2021.

While most children with COVID-19 only develop mild symptoms or have no symptoms at all, they are still able to pass along the virus to others.

In March, Pfizer released preliminary results from a vaccine trial involving more than 2,000 volunteers ages 12 to 15. The trial showed that none of the fully vaccinated adolescents came down with COVID-19 or experienced serious side effects.

In a related development on the vaccine front, introduction of another potential COVID-19 vaccine will be delayed until later this year. U.S.-based pharmaceutical company Novavax announced Monday it will not seek regulatory approval of its experimental vaccine until this July, citing problems in securing the raw materials and equipment needed to manufacture the vaccine.

But Novavax Chief Executive Stanley Erck told reporters on a conference call that the company expects to meet its goal of producing 150 million doses per month by the fourth quarter of this year.

Company officials said it expects to release the results of a late-stage clinical trial in North America sometime this month. A clinical trial conducted in Britain showed the vaccine is about 95-percent effective against the coronavirus.

Novavax has promised to supply more than 1 billion doses of the vaccine to the COVAX global vaccine sharing initiative for poor and middle-income nations, as well as 200 million shots to several European countries.

India

In other developments Monday, the World Health Organization said that a variant of the coronavirus circulating in India is of global concern.

"We classify it as a variant of concern at a global level," Maria Van Kerkhove, WHO technical lead on COVID-19, told a briefing on the B.1.617 variant. "There is some available information to suggest increased transmissibility."

The Philippines announced Tuesday that it had detected its first two cases of the Indian B.1.617 variant. The variant was discovered in two travelers who returned to the Philippines in April from Oman and the United Arab Emirates.

India’s daily COVID-19 statistics are down slightly but remain high. The Health Ministry reported 329,942 new infections in the previous 24-hour period Tuesday, including 3,876 deaths. Public health experts say they believe the new cases and deaths are undercounted.

Health workers and volunteers in personal protective suits wait to receive patients outside a COVID-19 hospital that was set up at a Sikh Gurdwara in New Delhi, India, May 10, 2021.
Health workers and volunteers in personal protective suits wait to receive patients outside a COVID-19 hospital that was set up at a Sikh Gurdwara in New Delhi, India, May 10, 2021.

India now has a total of 22.9 million COVID-19 infections and 249,992 deaths, according to the Johns Hopkins Coronavirus Resource Center. Only the U.S. has more infections, accounting for 32.7 million of the world’s 158.5 million cases, the center reported.

There is growing concern in India about a fungal infection affecting COVID-19 patients and people who have recovered from the disease. Mucormycosis is caused by mold and can affect a person’s facial structure. In some cases, it causes blindness. COVID-19 patients with diabetes are particularly susceptible to mucormycosis, medical experts said.

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