Thursday, October 21

Brussels joins a vital week: evaluate and authorize Pfizer’s vaccine

Thousands of containers of ice await to transport millions of Pfizer vaccines by community territory while Brussels joins in a vital week, pending that the European Medicines Agency (EMA) gives a favorable verdict that allows to issue a license to start vaccination campaigns.

The EMA Human Medicines Experts (CHMP) plan to finish this Monday read, verify and evaluate the data made available to you by Pfizer / BioNTech Pharmaceuticals with information on ingredients, production, non-clinical data and trial results on more than 40,000 volunteers, leading to a key conclusion about the safety, efficacy and quality of your covid-19 vaccine.

The beginning of the slow return to social life of the 446 million inhabitants of the European Union (EU) depends on the conclusions reached by the EMA: its positive opinion is subordinated that, in the middle of this week, the Commission The European Union grants the “Conditional Marketing Authorization” (CMA) to Pfizer. Get that license it is not “a magic formula” to return to normal life the next day, or in the coming weeks, but it will be the beginning of the end of a pandemic that hijacked this 2020: we will still have to launch vaccination campaigns, wait for the drug to take effect, see how immunity works and give the injection everyone (two doses, 21 days apart), even those who have been infected with SARS-CoV-2.

“While safe and effective COVID-19 vaccines will be a key component against the virus, by themselves they will not be the silver bullet that will allow us to return to normalcy. A consistent approach that combines social distancing, masks, tracing will continue to be necessary and other public health measures to control the spread for several months while vaccinations are carried out, “warned Emer Cooke, executive director of the EMA.

Conditions for the pharmaceutical

As long as national governments ensure that their citizens continue to maintain the minimal social contact In order not to infect family and friends, especially at a critical time like Christmas, the pharmaceutical companies that have developed the covid-19 vaccine will have one of the most important tasks.

By obtaining a CMA, and not a final and official license for the use of their vaccine in European territory, Pfizer and BioNTech are subject to very strict conditions by the EMA– Closely monitor the vaccination campaign in the EU to quickly identify any undetected side effects and keep the agency abreast.

The company is committed to having a plan for assess “any possible adverse effects new that is observed in the population, to assess whether it is attributable to the vaccine and, if linked, whether additional precautions must be taken “of which those responsible for vaccination must be notified.

For now Pfizer has only detected acceptable side effects common to other vaccines and medications, such as tiredness, headache, muscle or joint pain, fever, chills, and injection site discomfort. Less frequent were other symptoms, such as nausea and swelling and redness around the “prick.” There are groups in which research is still lacking, such as those under 16 and pregnant or breastfeeding women. Pfizer will have to continue studying this, pointing it out in a leaflet adapted to community regulation.

The vaccination campaign

The CHMP was scheduled to announce its conclusions on 29 December, but brought forward that date a week after receiving the last data package requested from Pfizer, just as it brought forward from January 12 to 6 the planned end of the CMA evaluation requested by the pharmaceutical company Moderna to distribute its vaccine in the EU.

Although everything will depend on the conclusions of the CHMP, the President of the Commission, Ursula von der Leyen, (who could authorize the use of the vaccine next Wednesday), established the December 27 as the start of the vaccination campaigns in member countries. “We are making good progress to guarantee vaccines,” the president celebrated, after the EMA brought forward the date for evaluating Moderna’s drug.

But starting before 2021 doesn’t seem feasible for everyone. While Spain or Germany mobilize to start next Sunday, The Netherlands rejects any possibility of launching its campaign before January 8 for technical reasons and until receiving the first doses, for which there is no date yet.

Those who yes they are ready are the carriers, with its containers full of dry ice and cold rooms to keep the doses at minus 70 degrees. Even 15 kilometers from the EMA headquarters, at Amsterdam Schiphol Airport, many trucks await patients for approval for the arrival of injections from Pfizer factories to be distributed throughout Europe.

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