Washington [US], February 1 (ANI): Moderna‘s COVID-19 vaccine ‘Spikevax‘ received full approval from the U.S. Food and Drug Administration (FDA), after more than a year of its “emergency use authorization”, reported USA TODAY.

The announcement was made by Moderna on Monday. “The totality of real-world data and the full (license) for Spikevax in the United States reaffirms the importance of vaccination against this virus. This is a momentous milestone in Moderna‘s history as it is our first product to achieve licensure in the U.S.,” Stephane Bancel, Moderna‘s CEO, said in a statement.

The full approval is for individuals 18 and older in the two-dose primary series for vaccination however, the booster dose is available under emergency use authorization only, reported the newspaper. Acting FDA Commissioner Dr Janet Woodcock said that the full approval of Moderna‘s COVID vaccine “may instil additional confidence” for those who have not yet been vaccinated.

“The public can be assured that Spikevax meets the FDA‘s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” Woodcock said. Notably, about 204 million doses have since been administered in the U.S., according to data from the Centers for Disease Control and Prevention. (ANI)

Pfizer, BioNTech seek emergency authorization for COVID-19 vaccine for kids under 5 years of age

New York [US], February 2 (ANI): The pharmaceutical companies, Pfizer and BioNTech, are seeking Emergency Use Authorization for their COVID-19 vaccine for use in children between six months and four years of age.

“Pfizer Inc and BioNTech SE today announced that following a request from the US Food and Drug Administration (FDA) the companies have initiated a rolling submission seeking to amend the Emergency Use Authorization (EUA) of the Pfizer–BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age (6 months to <5 years of age), in response to the urgent public health need in this population,” Pfizer and BioNTech said in a statement on Tuesday (local time).

If authorization is granted, the Pfizer–BioNTech vaccine would be the first COVID-19 vaccine available for pediatric populations under 5 years of age.

Pfizer and BioNTech said they expect to complete the EUA submission in the coming days. “As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

“Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Bourla added.

Ugur Sahin, MD, CEO and Co-founder of BioNTech, said that the vaccine has already demonstrated favorable safety, tolerability, and efficacy profile in multiple clinical trials and real-world studies for all age groups starting from 5 years old.

“If authorized, we are very excited about the prospect of offering parents the opportunity to help protect their children 6 months through 4 years of age from COVID-19 and the potentially severe consequences of infection,” Sahin added. (ANI)