WASHINGTON, D.C. (February 25, 2021—later this week the Food and Drug Administration, Vaccines and Related Biological Products Advisory Committee Meeting is poised to approve of the Johnson and Johnson COVID-19-vaccine.
Johnson & Johnson’s one-shot coronavirus vaccine appeared safe and effective in trials according to the US Food and Drug Administration (FDA) staff–in documents published on Wednesday, paving the way for emergency authorization in the United States (US).
“Our investigational vaccine produces an antigen, or protein, which should cause the body’s immune system to react and get rid of the novel coronavirus,” Dr. Redlich explains.
An advisory panel of independent experts will meet on Friday to decide whether to recommend the vaccine be authorized. While the FDA is not bound to follow the advice of its experts, the agency did so when authorizing the Pfizer and Moderna vaccines late last year.
“The SARS-CoV-2 pandemic presents an extraordinary challenge to global health and, as of February 17, 2021, has caused more than 110 million cases of COVID-19 and claimed the lives of more than 2.4 million people worldwide. In the United States, more than 27 million cases and
486,000 deaths have been reported to the Centers for Disease Control and Prevention (CDC).”
“On January 31, 2020, the U.S. Secretary of Health and Human Services (HHS) declared a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.”
“Following the World Health Organization’s declaration of the novel coronavirus pandemic on March 11, 2020, the U.S. President declared a national emergency in response to COVID-19 on March 13, 2020. Vaccines to protect against COVID-19 are critical to mitigate the current SARSCoV-2 pandemic and to prevent future disease outbreaks.”
The FDA said in their brief, “Safety analysis through the January 22, 2021 data cutoff included 43,783 randomized participants ≥18 years of age with 2-month median follow-up. The analysis supported a favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA.
“FDA issued emergency use authorizations for two mRNA vaccines, developed by Pfizer and Moderna, respectively, in December 2020. Other
COVID-19 vaccines currently in development are based on various platforms and include mRNA, DNA, viral vectored, subunit, inactivated, and live-attenuated vaccines. Most COVID-19 candidate vaccines express the spike protein or parts of the spike protein, i.e., the receptor binding domain, as the immunogenic determinant.”
FDA said, “as of January 22, 2021, 19 deaths were reported (3 vaccine, 16 placebo). Two deaths in the “vaccine group were secondary to respiratory infections not due to COVID-19. A 61-year-old participant died of pneumonia on Day 24 following onset of symptoms on Day 13. A 42-year-old participant with HIV died on Day 59 following diagnosis of a lung abscess on Day 33. A 66-yearold participant died of unknown causes after waking up with shortness of breath on Day 45. The placebo recipients died of pneumonia, suicide, accidental overdose, myocardial infarction, malaise, unknown cause and confirmed COVID-19. An update on deaths reported from the time period of January 22 to February 5 included an additional 6 deaths. Of these 6 deaths, 2 occurred in the vaccine group and 4, including 1 due to COVID-19, occurred in the placebo group. None were related to the study product.”
Non-fatal Serious Adverse Events
The proportions of participants who had at least one SAE reported through January 22, 2021 were 0.4% in the vaccine group and 0.4% in the placebo group. The most commonly reported SAE was appendicitis occurring in 6 vaccine recipients and 5 placebo recipients. There were no significant numerical imbalances in SAEs by preferred term.
Study participants of childbearing potential were screened for pregnancy prior to vaccination. Participants were excluded if they were pregnant or planned to become pregnant within 3 months of vaccine administration. The study is collecting outcomes for all reported pregnancies
in study participants.
FDA concluded “available data do not indicate a risk of vaccine-enhanced disease, and conversely suggest effectiveness against severe disease within the available follow-up period. However, risk of vaccine-enhanced disease over time, potentially associated with waning immunity, remains
unknown and needs to be evaluated further in ongoing clinical trials and in observational studies that could be conducted following authorization and/or licensure.
Read FDA Meeting Briefing