The European Medicines Agency has used rapid procedures to approve a new version of the Covid-19 vaccine to address the Omicron variant if the current vaccine turns out to be inadequate to fight it off. increase.
Authority director Emmer Cook told the European Parliament on Tuesday that regulatory approval could be completed three to four months after the company was ready to move forward, but the variant was on the current vaccine. He said tests are underway to assess how it reacts.
“At this stage, much of this work needs to be done at the enterprise level, but we guarantee that we are working with companies and other regulators to ensure that they are as prepared and ready as possible. I want to, “she said. “If you need to change your vaccine, you may be able to get approval within 3-4 months.”
In February, the EMA introduced new guidance for pharmaceutical companies on how to handle vaccine updates to address new variants. The agency asked the company to investigate how well Shot could tolerate existing mutations and set up what data and research would be needed to facilitate the adaptive version. Throughout the pandemic, regulators have used tools such as real-time review of test data to accelerate the approval process.
According to the guidance, vaccine manufacturers need to show the consistency of the already approved manufacturing process for new shots, and clinical data to support changes in vaccine efficacy or other important aspects. Is required.
For other mutations, such as the delta mutant, the vaccine has been shown to provide protection, although it is less effective. Concerns about Omicron variants are the number of mutations from the original strain to the peplomer, which is the target of most vaccines, especially for viruses to invade cells.
Pfizer Inc. Albert Bourla can tell Bloomberg Television how well the Covid-19 vaccine can tolerate new mutants within a few weeks, and even in the worst-case scenario, some existing prescriptions will be retained. He said he expected it. Efficacy for highly mutated strains. A senior executive at Moderna Inc. also said this week that many mutations in the Omicron variant suggest the need for a new vaccine.
“It’s very important to emphasize that we’re ready,” said Cook, who undertook the post a year ago. “We know that the virus will mutate. At some point, the mutation will occur and we need to change our current approach.”
EU drugstores can clear Omicron shots in 4 months if needed
Source link EU drugstores can clear Omicron shots in 4 months if needed