Virus World

The European Union drugs regulator has recommended granting Moderna's Covid-19 vaccine a conditional marketing authorization, a move that will soon pave the way for the drug to become the second coronavirus vaccine to be distributed in the bloc.  Following the recommendation by the European Medicines Agency (EMA), the shot now must be formally authorized by the European Commission, which is expected to do so quickly. On Wednesday, the European Parliament Committee on Environment, Public Health and Food Safety said on Twitter that they are "expected to follow the (EMA) recommendation and grant the authorization shortly after which the roll-out of the vaccine in the EU can begin. "Emer Cooke, EMA executive director, said on Wednesday that "this vaccine provides us with another tool to overcome the current emergency."  "It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO," she said. Ursula von der Leyen, president of the European Commission, said in a tweet that the EMA had found that the Moderna vaccine is "safe and effective" and that their decision is "Good news for our efforts to bring more #COVID19 vaccines to Europeans!" "Now we are working at full speed to approve it & make it available in the EU," she said. The EU has secured the purchase of up to 160 million doses of the Moderna vaccine -- enough to vaccinate 80 million people of its 448 million citizens -- as part of a joint vaccine strategy aimed to ensure equitable access across the bloc.  It has also purchased up to 300 million doses of the Pfizer/BioNTech vaccine, which was authorized for use on December 21 and rolled out to all EU countries days later.

In a landmark collective undertaking, the bloc is poised to start distributing shots to all 27 member nations and their 410 million citizens.  From Stockholm to Athens and from Lisbon to Warsaw, European Union governments are gearing up to receive a coronavirus vaccine later this week, even as cases keep rising in some parts of the continent. The bloc formally approved the Pfizer-BioNTech vaccine on Monday, setting off a logistical marathon the likes of which most of the authorities in the region have not had to contend with before. The operation to buy, approve and distribute the shots across the European Union has been complex and politically charged, and the stakes could not be higher. The pandemic’s second wave is still raging in parts of the region, most Europeans are spending the holidays in some type of lockdown, and the bloc’s economies are in tatters. To further complicate matters, a highly contagious variant in England led many European countries over the weekend to block travelers from Britain, although scientists say it has already reached the continent. If the vaccine mission is successful, it may bolster the credentials of the European Union, establishing its administration as a real force with executive powers and capabilities that can take on important tasks on behalf of its members. If not, the failure may spread acrimony and disaffection.

The European Medicines Agency, the bloc’s drug authority, gave its approval on Monday, after coming under intense scrutiny for the pace at which it reviewed the Pfizer-BioNTech vaccine. Britain granted the vaccine emergency approval weeks ago and then started rolling out its inoculation program, with the United States following not far behind. In the end, the European agency decided to speed up the process, moving forward an approval meeting that had been set for Dec. 29. The United States has also approved a vaccine from Moderna, but the European agency will not address the application for authorization of that company’s shots until Jan. 6. The agency’s authorization for the Pfizer-BioNTech vaccine was followed a few hours later by the final step, when the European Commission, the executive arm of the European Union,gave its approval, giving the green light for Pfizer to start distributing vaccines across the region.  “As we have promised, this vaccine will be available for all European countries at the same time, under the same conditions,” said Ursula von der Leyen, the European Commission president. “Let me say how proud I am that the first Covid vaccine available in Europe is a true product of the European innovation.”

The European Medicines Authority (EMA) will most likely not be able to approve the COVID-19 vaccine developed by drug maker AstraZeneca and the University of Oxford in January, the watchdog's Deputy Executive Director Noel Wathion said. 

AMSTERDAM (Reuters) - The European Medicines Authority (EMA) will most likely not be able to approve the COVID-19 vaccine developed by drug maker AstraZeneca and the University of Oxford in January, the watchdog’s Deputy Executive Director Noel Wathion said. “They have not even filed an application with us yet”, Wathion said in an interview with Belgian newspaper Het Nieuwsblad published on Tuesday. European regulators have only received some information about the vaccine, Wathion said. “Not even enough to warrant a conditional marketing licence”, he said. “We need additional data about the quality of the vaccine. And after that, the company has to formally apply.” This made it “improbable” that an approval could already be granted next month, Wathion said. The EMA could not be reached for comment.  AstraZeneca told Reuters last week that its COVID-19 vaccine should be effective against the new coronavirus variant, adding that studies were under way to fully probe the impact of the mutation. It has submitted a full data package about its vaccine to the British medicines regulator, British health minister Matt Hancock said.