According to recent statements by the Trump administration officials, under President Trump, the Food and Drug Administration cannot approve the latest seasonal COVID-19 vaccines for virus variations this year.
Since the severe phase of pandemic disease, vaccine manufacturers have been updated annually to target 19 shots annually to target the latest virus variations, which are permanently developed to avoid our immune response. Until now, the FDA has treated these tackle vaccines in the same way that it treats seasonal flu shots, which is currently updated annually to meet the stress of the flu virus.
The FDA does not consider seasonal flu shots to consider new vaccines at all. In fact, they are just a slightly changed version of the approved vaccine. Similarly, the regulator does not have to hold long, expensive vaccine trials from companies to prove that every slightly changed version is safe and efficient. If they did so, it would be practically impossible to produce an annual vaccine. Every year, from the end of February to the beginning of MarchWhat should they compose for the upcoming flu season on FDAs, Disease Control and Prevention Centers, and Directorate Flow Shot makers of the World Health Organization. This gives manufacturers plenty of time to adapt and start manufacturing large -scale equipment on time for the start of the flu season.
So far, the covid -19 vaccines have been treated exactly the same way, save the fact that vaccines using MRNA technology do not require so much lead time for manufacturing. In recent years, the FDA has decided on the annual coordinated formulations around June, with flu shots as well as food.
However, the process is now based on the statements of the Trump administration officials. These statements have come to the forefront of the decision whether to approve the Kavid -19 vaccine through Novaks, which uses not MRNA but uses protein -based technology. The FDA had to decide whether the vaccine was to be fully approved by April 1. Until then, this vaccine has been used by the agency for an emergency use.