Jan 14, 2022
EMA asked to add another adverse event to the label of Vaxzevria and Janssen COVID19 vaccine
EMA asked to change the label of Vaxzevria and Janssen's vaccine; it recommended adding transverse myelitis (TM) as an adverse event to raise awareness among the physicians and citizens who are taking the vaccines. It further mentioned that these adverse events are rare and are of unknown frequency.
Transverse myelitis is a condition in which inflammation occurs on one or both sides of the spinal cord. It causes weakness in the arms or legs, sensory symptoms, or bowel function problems.
EMA has said there is a relationship between the administration of vaccines and adverse events.
Jan 07, 2022
US FDA shortened the interval between the primary doses and booster dose of Moderna vaccine to 5 months
The US FDA announced that it had amended the emergency use authorization of the Moderna vaccine for the booster dose. The time gap has been reduced to five months between the primary doses and booster dose of the Moderna vaccine for individuals greater than 18 years of age.
The most common adverse events reported are pain, swelling, and redness.
CDC endorsed ACIP's recommendation on Janssen's vaccine
CDC has endorsed the Advisory Committee on Immunization Practices (ACIP) recommendation to prefer mRNA vaccines over Janssen's vaccine to prevent COVID19 infection. The guidance was based on the safety, efficacy, and vaccine supply. The recommendation is in line with the advice of other countries, including Canada and the United Kingdom.
CDC announced that the US has an excess of mRNA vaccines - about 100 million for immediate use. Pfizer-BioNTech and Moderna vaccines are currently available mRNA vaccines in the US.
Further, CDC recommended taking some vaccines rather than being unvaccinated.
Janssen, in its statement, mentioned that it is working with CDC on recommendations. The company said that its vaccine stimulates a strong antibody response.
Health Canada approved Janssen's vaccine to prevent COVID-19
Johnson and Johnson announced that Health Canada had approved the single-shot COVID19 vaccine in Canada for adults 18 years and older.
The approval is based on the Phase 3 ENSEMBLE study. The vaccine effectively prevented severe disease in 85% of the population, demonstrating protection against severe disease and death after 28 days of vaccination. The study enrolled 43,783 patients.
Janssen developed the COVID19 vaccine using the AdVac vaccine platform.
European Commission approved Novovax and SII's vaccine Nuvaxovid
The European Commission has announced that it has approved the fifth vaccine to prevent the COVID-19 infection. The commission has announced that the approval is based on the efficacy and safety of the vaccine. Two vaccine doses should be given with a time difference of three weeks.
The approval is based on two clinical trials which enrolled more than 45,000 participants. In the first study conducted in the US and Mexico, two-thirds of participants were administered with the vaccine, and the others were given a placebo. The efficacy of the vaccine was 90.4%.
In the second study, which included the participants from the United Kingdom, half the participants were administered with the vaccine, and the other half were administered with a placebo. The efficacy of the vaccine was 89.7%.
The vaccine was approved in Indonesia. Approval requests were submitted for the regulatory agencies in India and Indonesia, and an emergency use application was submitted to the WHO. Further, the companies seek regulatory approval in Canada, the US, and Australia.