U.S. regulators have authorized the COVID-19 vaccine developed by Pfizer-BioNTech to be used by children as young as 12, 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.
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 preliminarily 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 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.”
India’s daily COVID-19 statistics are down slightly but remain high. The Health Ministry said Monday there were 366,161 new infections and 3,754 deaths caused by the coronavirus in the previous 24-hour period. Public health experts say they believe the new cases and deaths are undercounted.
India has 22.7 million COVID-19 cases so far, 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.
Nepal, struggling to combat an outbreak of the pandemic, is running short of oxygen and oxygen tanks. The Himalayan country has asked Mount Everest climbers and guides not to abandon their oxygen cylinders on the mountain and instead bring them back down so that medical facilities can fill them to give to COVID-19 patients.
Kul Bahadur Gurung, a senior official with the Nepal Mountaineering Association, told Reuters, “We appeal to climbers and Sherpas (Himalayan people living around Nepal and Tibet, well-known for climbing mountains) to bring back their empty bottles wherever possible, as they can be refilled and used for the treatment of the coronavirus patients who are in dire need.”
A Nepal Health Ministry official speaking to Reuters said the country needs 25,000 oxygen tanks immediately.
The Czech Republic said Monday it would open bars and restaurants for outdoor dining beginning in a week because of falling numbers of coronavirus infections.
In Britain, Prime Minister Boris Johnson said people would be allowed next week to resume giving hugs to those outside their household bubbles.
He said beginning next Monday, people would be permitted to meet indoors in groups of up to six people. Also, pubs, cafes and restaurants will be able to serve people indoors, subject to certain rules.
During a weekend summit in Portugal, the European Union approved a contract extension with Pfizer to provide up to 1.8 billion additional doses of its vaccine through 2023.
Pfizer has provided the EU with 600 million doses, as required in the initial contract.
Also at the summit, the U.S. faced mounting criticism from EU leaders over President Joe Biden’s surprise endorsement last week of lifting COVID-19 vaccine patents to make more doses available to poorer countries.
“We don’t think, in the short term, that it’s the magic bullet,” said EU Council President Charles Michel.
Michel and other EU leaders said the U.S. should, instead, start boosting vaccine exports to have maximum impact on the global pandemic.
The United States, like Britain, has limited exports of domestically developed vaccines so it can inoculate its population first. The EU has become the world’s leading vaccine provider, distributing about 200 million doses to the 27-nation bloc and roughly an equal number to nearly 90 countries around the world.