Washington, The pharmaceutical company AstraZeneca will file a request for approval of its novel coronavirus vaccine in the United States later this year, the company said in a statement.
Earlier this year, concerns emerged over side-effects of the AstraZeneca vaccine due to very rare cases of blood-clotting after vaccination. After some nations temporarily suspended use of the vaccine, the WHO said it considers the benefits of the drug to outweigh its risks.
“We continue to work with the FDA [US Food and Drug Administration] on submission,” the company said on Wednesday. “Currently, the situation with respect to the pandemic and availability of alternative vaccine supply in the US doesn’t really support an Emergency Use Approval. So, we believe that US approval will be via a BLA [Biologics License Applications] which we expect to be submitted later this year.”
The FDA has so far authorized three vaccines for emergency used across the United States, including Pfizer, Moderna and Janssen.
In February 2021, the World Health Organization listed two versions of the AstraZeneca/Oxford COVID-19 vaccine for emergency use, giving the green light for these vaccines to be rolled out globally through the COVAX mechanism.
According to AstraZeneca, its vaccine shows 92 percent and 86 percent efficiency against hospitalization in the Delta and Alpha variant cases, respectively. At the same time, a UK-based study from May, published in the New England Journal of Medicine on July 21, showed that AstraZeneca was 33% effective after one dose, 60% effective after two.