COVID-19: AstraZeneca to seek US regulatory approval for vaccine later this year

British-Swedish biopharmaceuticals company AstraZeneca has intended to seek full regulatory approval of COVID-19 vaccines from the United States Food and Drug Administration (FDA) later this year. Even after the company has delivered more than a million doses across the world, the necessity to review its approval came after concerns emerged over the side effects of the AstraZeneca vaccine, the Associated Press reported. Meanwhile, to allow the full authorisation, the US vaccine regulators have requested the company to produce extensive clinical trial reports as a part of the "biologics license application (BLA)."

Plans for AstraZeneca's COVID-19 is of crucial importance as it has slipped the approval timetable in recent months. The company was supposed to file for BLA after it released its US-based clinical trial data in April. "We continue to work with the FDA on submission. Currently, the situation with respect to the pandemic and availability of alternative vaccine supply in the US does not readily support an emergency use approval. So we believe that US approval will be BLA which we expect to be submitted later this year," the company said in a statement.

"We have an enormous amount of clinical data coming from the work we've done around the world. A BLA is a much bigger submission than the EUA..." AP quoted AstraZeneca CEO Pascal Soriot as saying at a  conference.

As per AP reports, AstraZeneca currently has received approval from more than 170 countries. Throughout the pandemic, it had largely promoted the COVID-19 vax as inexpensive and easy-to-handle shots. It has also distributed millions of doses on a non-profit basis to bolster the vaccination process in low and middle-income countries. "There is still so much to do, and all in the supply chain are pushing on knowing the next billion people are still waiting for the doses," the director of The Oxford vaccine group Andrew Pollard said earlier in July.

AstraZeneca could 'play a role in the future'

The US is currently "well-supplied" with vaccines. However, as per Soriot, AstraZeneca could "play a role in the future." Meanwhile, the US FDA and Center for Disease Control and Prevention (CDC) have approved the use of Pfizer-BioNTech COVID-19 booster doses for eligible adults aged between 18-65 years of age. The shots will be allowed only after a candidate has covered six months since his/her first Pfizer vaccine. According to a bulletin released by the CDC, about 22 million Americans are currently eligible for booster jabs. Specifying the eligibility criteria, the CDC also mentioned that the booster doses will be available for people who are considered mildly or severely immunocompromised. People under specific medications, who might suffer from decreased immune systems may also register for the jab.

(With inputs from agencies)

(Image: AP/ PIXABAY)