Virus World
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Virus World
Virus World provides a daily blog of the latest news in the Virology field and the COVID-19 pandemic. News on new antiviral drugs, vaccines, diagnostic tests, viral outbreaks, novel viruses and milestone discoveries are curated by expert virologists. Highlighted news include trending and most cited scientific articles in these fields with links to the original publications. Stay up-to-date with the most exciting discoveries in the virus world and the last therapies for COVID-19 without spending hours browsing news and scientific publications. Additional comments by experts on the topics are available in Linkedin (https://www.linkedin.com/in/juanlama/detail/recent-activity/)
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E.U. Agency Approves Pfizer Covid Vaccine - The New York Times

E.U. Agency Approves Pfizer Covid Vaccine - The New York Times | Virus World | Scoop.it

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 commission hands over responsibility for this first load as the cargo departs Pfizer factories in Puurs, Belgium, and in Mainz, Germany, headed for European capitals, most likely on Thursday. The company, which declined to answer detailed questions about transportation plans for security reasons, will play an active role in vaccine transport and storage in each country. From that point on, each of the bloc’s 27 member governments will be responsible for distributing the vaccine to its population in a manner that fits each country’s needs, priorities and capabilities. The first Europeans are expected to be inoculated on Dec. 27, 28 and 29. The pressure to get this right, and to do so quickly, has been mounting as the European Union and its members try a collective approach in a critical node in the fight against the pandemic. Most countries have been more nationalistic.  The European approach began with the decision this summer to pool negotiating capital and to empower the European Commission and a board of representatives from every member country to reach agreements with pharmaceutical companies working on vaccines. There has been criticism that the European Union, like the United States, did not order enough doses of the Pfizer-BioNTech vaccine when given a chance. But from a financial perspective, it appears that the approach did benefit the bloc: It is paying less than the United States for the Pfizer-BioNTech vaccine....

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BioNTech, Pfizer Start Rolling EMA Approval Filing for COVID-19 Vaccine

BioNTech, Pfizer Start Rolling EMA Approval Filing for COVID-19 Vaccine | Virus World | Scoop.it

BioNTech and Pfizer have started a rolling submission of their COVID-19 vaccine BNT162b2 to the European Medicines Agency (EMA). The news comes days after EMA named AstraZeneca's AZD1222 as the first COVID-19 vaccine to start the rolling review process. The EMA uses rolling reviews to start assessing data on an experimental candidate before all the evidence needed to make a final decision is available, cutting the time it takes to decide whether to approve a prospect once the pivotal clinical trial results are submitted to the agency. The pressing need for COVID-19 vaccines potentially makes the mechanism important to the current crisis. After receiving the first part of a rolling submission, the EMA’s Committee for Medicinal Products for Human Use has begun evaluating the preclinical evidence on mRNA vaccine BNT162b2. The rolling review format provides opportunities to file additional data before the complete application. Each cycle typically requires a two-week review. The duration of the review of the final application will depend on the proportion of data already assessed by EMA under the rolling review. 

 

The EMA accepted BNT162b2 for rolling review on the strength of the preclinical and early clinical data on the vaccine. BioNTech and Pfizer have linked BNT162b2, which encodes a SARS-CoV-2 spike glycoprotein, to antibody and T-cell responses in people dosed in early-phase trials. The data led the partners to start a phase 3 clinical trial. That trial has now enrolled around 37,000 participants at sites in countries including the U.S., Brazil, South Africa and Argentina, with centers in Turkey coming online to help push BioNTech and Pfizer to their enrollment target of 44,000 subjects. More than 28,000 participants have received their second dose. BioNTech and Pfizer originally planned to enroll 30,000 subjects. The enrollment figures suggest BioNTech and Pfizer are closing in on the release of top-line data from the trial. Exactly how long the partners need to wait for efficacy data will depend on the extent to which participants have been exposed to the virus and the effectiveness of the vaccine. BioNTech and Pfizer are set to perform interim efficacy analyses when there are 32, 62, 92 and 120 COVID-19 cases in the trial...

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