It is difficult for Europe to have the nCoV vaccine on time by the end of this year

Representatives of the European pharmaceutical management agency said that even with an urgent evaluation of the two leading "candidates", it is difficult to complete it at the end of the year.

Mr. Guido Rasi, Executive Director of the European Pharmaceutical Agency (EMA) shared about the progress of nCoV vaccine approval in the continent in an interview held on October 8. Technically, he said, Europe's "candidates" would be qualified. But the reality is that the licensing of Covid-19 vaccine in 2020 is very unlikely.

"It is mid-October now. Even if pharmacies submit their 'candidate' clinical trial data for several weeks it takes quite a while to proceed with further evaluation steps, at least. wait until the end of the year, "said Mr. Rasi.

Technical staff is collecting experimental nCoV vaccines from a glass vial at a European research lab. Photo: Andrey Rudakov / Bloomberg.

Covid-19 pressure is increasing globally, especially as the number of infections has skyrocketed, exceeding 36 million cases. Some countries re-apply social restrictions and distancing measures, threatening their economies again. The EMA has begun evaluating real-time data rotation to speed potential vaccine approval. The pharmaceutical firms in the leading group include two duo AstraZeneca - University of Oxford and Pfizer - BioNTech.

The first "candidates" for vaccines may be offered conditional marketing licenses, Rasi said. However, this is only temporary approval for a one-year period, provided the benefits of product launch immediately outweigh the risks posed by the data source. The EMA representative added that regulators will need to know the effective timing of the injections, before fully authorizing them to circulation.

European Union countries can still use national emergency rights to distribute vaccines prior to EMA approval. He formulated a plan in August, proceeding to amend the law and clarify his authority. Their aim was to soon license the emergency use of a Covid-19 vaccine in its territory. However, the decision to speed up the approval process may raise concerns about the safety of the vaccine. Countries should focus on vaccine delivery plans, rather than trying to get the shots early, Rasi said.

On the other hand, although each country has the right to issue emergency vaccines in their own country, the EMA representative does not encourage this "go ahead" action. "If a country tries to stay ahead of the EMA, it could be seen as a rush to delay the complete vaccine. Not to mention public confidence in the safety and efficacy of vaccines." decline, "he said.

Prior to that, the US regulator had halted AstraZeneca's terminal tests in its home country. This is not a big problem, Mr. Rasi said. AstraZeneca told analysts this week that it expects an update within the next one to two weeks of the suspended testing. Trials continue to take place in the UK, Brazil and South Africa, after tackling issues related to a volunteer suddenly becoming infected.

Mr. Guido Rasi said he would resign on November 15. Ms. Emer Cooke will replace him to accept the leadership position of EMA. Before that, Ms. Cooke held a leadership position in the pharmaceutical management department at the World Health Organization (WHO).

Information on the clinical trial process of the top "candidates" may be released this month, including results from the dual injection regimen of the duo Pfizer and BioNTech. Data from AstraZeneca's Oxford Global Vaccine Trials may also be released in the coming weeks.