Pfizer expects FDA emergency approval of its COVID-19 vaccine for young children

US-based drugmaker Pfizer and its German-based partner BioNTech are expected to ask the Food and Drug Administration on Tuesday to authorize their COVID-19 vaccine for children under the age of five.

Both companies will ask the FDA to grant emergency use authorization to give low doses of their two-shot vaccine to babies starting at six months of age, even though they announced back in December that the vaccine did not induce an immune response in children. Is. The age of 2 to 4 years is similar to that of adolescents and adults. The two companies had decided to add a third shot to their clinical trials, a move that could backfire on efforts to make the vaccine available to young Americans.

But health experts urged Pfizer and BioNTech to go ahead and request the FDA for a two-shot regimen while they await the results of trials involving a third shot. If both the FDA and the US Centers for Disease Control and Prevention grant final emergency approval, the vaccine could be available for use in late February.

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

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

Novavax received $1.6 billion from the US government through Operation Warp Speed, a program designed under the administration of former US President Donald Trump to quickly develop new coronavirus vaccines, but several delays due to a lack of manufacturing capacity. had to face. The vaccine has already been authorized by Indonesia, South Korea, India and the European Medicines Agency, the drug regulator for the European Union of 27 countries. It is expected to play an important role in increasing the supply of the vaccine to low- and middle-income countries as it does not need to be stored at ultracold temperatures, unlike Pfizer or Moderna vaccines.

File photo shows a view of a garbage basket with syringes and gloves as residents received a dose of the third Pfizer COVID-19 vaccine, at the San Jeronimo Nursing Home, Estella, northern Spain, September 23. 2021.

File photo shows a view of a garbage basket with syringes and gloves as residents received a dose of the third Pfizer COVID-19 vaccine, at the San Jeronimo Nursing Home, Estella, northern Spain, September 23. 2021.

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

The WHO report states that 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 insects.

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

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