FDA has issued Emergency Use Authorization for third COVID-19 vaccine: Janssen COVID-19 Vaccine
The FDA ( U.S. Food and Drug Administration ) has issued an emergency use authorization ( EUA ) for the third vaccine for the prevention of coronavirus disease 2019 ( COVID-19 ) caused by severe acute respiratory syndrome coronavirus 2 ( SARS-CoV-2 ).
The FDA has determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuance of an EUA.
The totality of the available data provides clear evidence that the Janssen COVID-19 Vaccine may be effective in preventing COVID-19.
The data have also shown that the vaccine’s known and potential benefits outweigh its known and potential risks, supporting the request for the vaccine’s use in people 18 years of age and older.
The Janssen COVID-19 Vaccine is manufactured using a specific type of virus called adenovirus type 26 ( Ad26 ). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive spike protein of the SARS-CoV-2 virus.
While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness.
After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.
The Janssen COVID-19 Vaccine is administered as a single dose. The available safety data to support the EUA include an analysis of 43,783 participants enrolled in an ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S.
The participants, 21,895 of whom received the vaccine and 21,888 of whom received saline placebo, were followed for a median of eight weeks after vaccination.
The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and lasted 1-2 days.
The effectiveness data to support the EUA include an analysis of 39,321 participants in the ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. who did not have evidence of SARS-CoV-2 infection prior to receiving the vaccine.
Among these participants, 19,630 received the vaccine and 19,691 received saline placebo. Overall, the vaccine was approximately 67% effective in preventing moderate to severe / critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe / critical COVID-19 occurring at least 28 days after vaccination.
Additionally, the vaccine was approximately 77% effective in preventing severe / critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.
There were 116 cases of COVID-19 in the vaccine group that occurred at least 14 days after vaccination, and 348 cases of COVID-19 in the placebo group during this time period.
There were 66 cases of COVID-19 in the vaccine group that occurred at least 28 days after vaccination and 193 cases of COVID-19 in the placebo group during this time period.
Starting 14 days after vaccination, there were 14 severe/critical cases in the vaccinated group versus 60 in the placebo group, and starting 28 days after vaccination, there were 5 severe / critical in the vaccine group versus 34 cases in the placebo group.
At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person. ( Xagena )
Source: FDA, 2021
Updated data from GARNET cohort F evaluating Dostarlimab in mismatch repair-deficient ( dMMR ) non-endometrial advanced solid cancers were presented at...
Rinvoq for the treatment of psoriatic arthritis and ankylosing spondylitis, approved by European Commission
The European Commission ( EC ) has approved Rinvoq ( Upadacitinib, 15 mg ), an oral, once daily selective and...
Opdivo in combination with Cabometyx as first-line treatment for patients with advanced renal cell carcinoma, approved by FDA
The FDA ( U.S. Food and Drug Administration ) has approved Opdivo ( Nivolumab ) 240 mg injection for intravenous...
Bavencio for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma, approved by European Commission
The European Commission ( EC ) has approved Bavencio ( Avelumab ) as monotherapy for the first-line maintenance treatment of...
EMA ( European Medicines Agency ) has recommended granting a conditional marketing authorisation for COVID-19 Vaccine AstraZeneca to prevent coronavirus...
Xalkori for children and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma, approved by FDA
The Food and Drug Administration ( FDA ) has approved Xalkori ( Crizotinib ) for pediatric patients 1 year of...
Keytruda as first-line treatment in adult patients with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer, approved by European Commission
The European Commission has approved Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, as a monotherapy for the first-line treatment of...
FDA has approved Breyanzi ( Lisocabtagene maraleucel ), a new CAR T cell therapy for adults with relapsed or refractory large B-cell lymphoma
The U.S. Food and Drug Administration ( FDA ) has approved Breyanzi ( Lisocabtagene maraleucel; Liso-cel ), a CD19-directed chimeric...
FDA has approved Tepmetko, an oral MET inhibitor for patients with metastatic non-small cell lung cancer and METex14 skipping alterations
The FDA ( US Food and Drug Administration ) has approved Tepmetko ( Tepotinib ) for the treatment of adult...
CHRYSALIS study: Amivantamab has shown clinical activity and durable responses in patients with metastatic or unresectable non-small cell lung cancer and EGFR exon 20 insertion mutations
New data from the phase 1 CHRYSALIS study, which has evaluated Amivantamab in patients with metastatic or unresectable non-small cell...