Regkirona medicine and the third dose of the vaccine: Two important decisions made by the EMA today
The European Medicines Agency has given the green light for the third dose of the Pfizer vaccine for people over 18 years of age. According to the EMA, people with weakened immunity will be able to get the third dose of Pfizer and Moderna vaccine at least 28 days after the second dose. The decision comes after several European countries have already launched the campaign, following estimates that the extra dose increases the ability to produce antibodies against Covid, in patients with weakened immune systems and in those who have undergone organ transplants.
EMA took another important decision today, announcing that it has begun evaluation on the testing application of Regkirona monoclonal antibodies (Regdanvimab, also known as CT-P59) to treat adults with COVID-19 who do not require additional oxygen therapy. and who are at increased risk of serious illness to Covid.
The applicant is Celltrion Healthcare Hungary, part of Celltrion Healthcare of South Korea. The EMA will assess the benefits and risks of Regkirona under a reduced timeframe and may issue an opinion within two months, depending on the data presented. Such a short period of time may be acceptable to give opinions, as the EMA has already reviewed some data on the drug.