Moderna, Pfizer-BioNTech and Johnson & Johnson have not received emergency approval for their vaccines
Friday’s announcement by the companies indicated that the Food and Drug Administration will review the full approval of the Pfizer BioNTech COVID-19 vaccination for people 16 and older.
FDA granted the “priority” designation to the Biologics License Application (BLA), which was submitted in May. It included data from late-stage trials on safety and efficacy for six months after the second dose. In April, 927 cases of symptomatic COVID-19 were confirmed (850 in the placebo group and 77 in vaccinated groups). These findings suggested that the vaccine was 91.3% efficient up to six months following the second dose.
The vaccine’s ability to protect against severe COVID-19 varied from 95.3% up to 100%, depending on the definitions used by FDA and Centers for Disease Control and Prevention. The vaccine’s protection against severe COVID-19 was 95.3% to 100% depending on the definitions used by the FDA and Centers for Disease Control and Prevention (CDC), respectively.
Fox News was informed by a spokesperson for the FDA that the FDA expects to complete the review well in advance of January’s target date.
Albert Bourla CEO of Pfizer, praised the results, which included high protection against a worrying viral variant first discovered in South Africa. Nine cases of COVID-19 were found in the placebo group of a study that involved 800 participants from South Africa. This translated to a 100% vaccine efficacy. Sixteen of the nine cases were linked to the virus variant after sequencing. Although the vaccine provided less protection against the variant than the original strain, the company and public officials claim that the vaccine is still highly effective.
Although no COVID-19 vaccine has been approved by the FDA, it has granted emergency use authorization (EUA), to vaccines created by Johnson & Johnson, Moderna, and Pfizer-BioNTech.
Pfizer also indicated its intent to file an emergency authorization for a COVID-19 boost shot. However, the FDA and CDC stated that fully vaccinated Americans do not require additional doses. According to the health agencies, the United States “is blessed to have highly effective vaccines that can be easily accessible” to all eligible people. Nevertheless, a panel advising the CDC will consider additional doses for the COVID-19 vaccine to a small portion of people with weak immune systems.
According to a draft agenda, the Advisory Committee on Immunization Practices will meet on July 22 to discuss “clinical concerns for additional doses in immunocompromised persons.”
According to the National Institutes of Health, immunocompromised patients are those who have a decreased ability to fight infections or other diseases. This could be caused by conditions such as “AIDS, cancer and diabetes” or medications or treatments like chemotherapy or organ transplants.
There is evidence that immunocompromised people, which make up 2.7% of the country’s population have a reduced immune response to vaccines. One study found that 7 to 27 days after the second Pfizer dose, 75% of patients with immunocompromised had protection against symptoms COVID-19, as opposed to 94% overall. Patients also experienced less protection from infection after receiving two Pfizer doses, at 71% versus 90%.