Five key aspects of the European decision on vaccines

THE HAGUE: The European Medicines Agency (EMA) will decide on Monday (December 21, 2020) whether to give the green light to the Pfizer-BioNTech coronavirus vaccine within the EU. The Amsterdam-based regulator pushed the decision forward eight days under pressure from EU states, after Britain and the United States approved the jab more quickly. Here are the key things to know about the decision:

The EMA is the regulator of all medicines for humans and animals in the 27 nations of the European Union. It tests medications and vaccines to determine their safety and effectiveness. Britain is also bound by its rules until the end of the post-Brexit transition period on January 1. The EMA moved from London to Amsterdam in 2019 after Britain left the EU.

The EMA Committee for Medicinal Products for Human Use will decide whether to recommend the approval of a one-year Conditional Marketing Authorization (CMA) for the Pfizer-BioNTech coronavirus vaccine in the EU. The regulator can grant a CMA for a drug during public health emergencies when it can show that the benefits of using it outweigh the risks of speeding up a process that normally takes years.

The EMA has been conducting a so-called “ongoing review” of the vaccine’s laboratory test data and clinical trials as they are received. Normally, you would only review the data after all of it has been collected. The American company Moderna will make a decision on the vaccine in a meeting on January 6.

Britain, the United States, Canada, Switzerland, Singapore and Bahrain have given the green light to the Pfizer-BioNTech vaccine, meaning that vaccination could begin. The EMA was originally going to decide on the vaccine on December 29, but pushed the date forward eight days after Germany and other European states complained about the delay. If the EMA committee does not reach a decision on Monday, it will hold another meeting on December 29.

The EMA says Britain and the US have only granted temporary authorization for emergency use of the vaccine, which requires fewer tests and needs to be renewed more frequently. On the contrary, it says that the conditional marketing authorization requires a more rigorous testing procedure, and that it lasts for one year, with subsequent follow-up tests. It is also “paramount” to ensure public confidence in the vaccine at a time when skepticism and misinformation abound, an EMA source told AFP.

British ministers said yes. But it later emerged that Britain was still under EU rules during the Brexit transition, yet it was allowed to opt out of emergencies. All EU states were allowed to do so, but they made the political decision to go together to the CMA to show unity and start vaccinations at the same time.

Arguably, Brexit had an effect because the EMA was slow to recover to full capacity after its move from London, according to a mid-year report in October. But there were other factors as well, as EMA’s new director Emer Cooke only started working in November. The agency also had to deal with a major cyber attack in which documents related to the Pfizer-BioNTech and Moderna vaccines were stolen, although it insisted the attack did not affect the vaccine schedule.

European Union experts believe existing coronavirus vaccines are effective against the rapidly spreading new strain identified in Britain, Germany’s health minister said on Sunday. “Based on all we know so far,” the new strain “has no impact on vaccines,” which are still “just as effective,” Jens Spahn told public broadcaster ZDF, citing “conversations between experts from the authorities. European “.

An independent panel of experts advising the Centers for Disease Control and Prevention voted Saturday to endorse a second coronavirus vaccine for use in adults 18 and older. The committee’s recommendation, by a vote of 11-0 (with three challenges due to conflicts of interest), followed Friday’s announcement that the vaccine, made by Moderna, had received an emergency clearance from the Food and Drug Administration. .

The advisory committee endorsement now awaits final approval from CDC Director Dr. Robert Redfield, which is expected shortly. The committee vote tells hospitals and physicians that they can proceed to inoculate patients with the Moderna vaccine. 5.9 million doses were scheduled to ship on Sunday and the first vaccines are expected to begin Monday.

Unlike the Pfizer-BioNTech vaccine, which has been licensed for use in people over 16 years of age, Moderna’s inoculations are intended for adults only. (Moderna didn’t begin her pediatric studies until December 9, and she didn’t expect to have a full data set until next year.) In adults, Moderna’s vaccine was more than 94% effective in preventing symptomatic cases of COVID-19. It is not yet clear how well the two vaccines are doing in curbing the transmission of the coronavirus.

Much of the advisory committee’s deliberations focused on reported serious allergic reactions after injections of the Pfizer-BioNTech vaccine, which contains ingredients similar to those in Moderna’s recipe. Now six cases of anaphylaxis have been documented in the United States, as well as two in Great Britain. Also, milder allergic reactions have been reported. Experts have said that these cases should not deter the vast majority of people from receiving the vaccine. More than 272,000 doses of Pfizer’s vaccine have already been distributed nationwide.

Half of the people who received Moderna’s vaccine in clinical trials also reported some uncomfortable symptoms, such as fatigue, headaches, and pain, after their second injection, given about four weeks after their first. Some volunteers also developed a fever or rash around the injection sites.