Pfizer Expected to Seek FDA Emergency Approval of its COVID-19 Vaccine for Young Children

U.S.-based drugmaker Pfizer and its German-based partner BioNTech is expected to ask the Food and Drug Administration Tuesday to grant authorization of its COVID-19 vaccine for children under five years old.

The two companies will ask the FDA to grant emergency use authorization to administer a low dose of its two-shot vaccine to children starting at six months old, even though they announced back in December that the vaccine did not produce an immune response in children between the ages of 2 to 4 years old similar to that of teenagers and adults. The two companies had decided to add a third shot to their clinical trials, a move that could have set back efforts to make the vaccine available for younger Americans.

But health experts urged Pfizer and BioNTech to go ahead and make the request to the FDA for the two-shot regimen while they wait for results of tests involving the third shot. The vaccine could be available for use as soon as late February if both the FDA and the U.S. Centers for Disease Control and Prevention grant final emergency approval.

Meanwhile, another U.S.-based pharmaceutical company, Novavax, announced Monday that it had submitted a request to the FDA for approval of its long-delayed COVID-19 vaccine for emergency use.

The two-shot vaccine was developed by a conventional method that uses proteins to teach the body’s immune system how to recognize and block the coronavirus. Clinical trials revealed the vaccine was about 90 percent effective at providing enough immunity to protect against the initial version of the disease and its variants. Experts say that technology could appeal to people who are hesitant to be inoculated with vaccines developed by Pfizer or Moderna that use the more advanced messenger RNA technology.

Novavax received $1.6 billion from the U.S. government through Operation Warp Speed, the program created under the administration of former U.S. president Donald Trump to quickly develop new coronavirus vaccines, but faced numerous delays due to a lack of manufacturing capacity. The vaccine has already been authorized by Indonesia, South Korea, India and the European Medicines Agency, the drug regulator for the 27-nation European Union. It is expected to play an important role in boosting vaccine supplies for low and middle-income nations because it does not have to be stored at ultracold temperatures, unlike the Pfizer or Moderna vaccines.

A report released Tuesday by the World Health Organization reveals the coronavirus pandemic has created tens of thousands of tons of extra medical waste, such as used needles, syringes and vials. The report found that most of the 87,000 tons of personal protective equipment (PPE), such as masks and rubber gloves, that were procured through a United Nations emergency initiative between March 2020 and November 2021 has ended up as waste.

The WHO report says the discarded material puts health care workers at risk of work-related injuries such as needle sticks, burns and disease-causing germs. Communities near poorly managed landfills are also at risk of contaminated air and water from burning waste and disease-carrying pests. 

Some information for this report came from the Associated Press (Reuters, Agence France-Presse).