European Medicines Agency launches first step of authorisation process for Russian vaccine Sputnik V
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Independent, scientific review particularly important in this case / Questionable whether Sputnik V can help us quickly / 6 vaccine manufacturers have already moved on
The European Medicines Agency (EMA) today launched a so-called rolling review procedure for the Russian vaccine Sputnik V. This is the first step in the EU's vaccine authorisation process. The Russian Gamaleja Institute of Epidemiology and Microbiology now has the opportunity to gradually submit its scientific findings on the efficacy, safety and quality of the vaccine. The scientific experts will review these and if this scientific analysis is positive, a marketing authorisation application can be officially submitted. Sputnik is the seventh vaccine now being examined in this procedure. In addition to the three authorised vaccines from Biontech/Pfizer, Moderna and AstraZeneca and the vaccine from Johnson&Johnson whose authorisation is expected on 11 March, the American company Novavax and the German-based company Curevac long ago begun the rolling review.
“Sputnik is therefore only number seven in this question,” noted MEP and health policy spokesperson of the largest group in the European Parliament (EPP-Christian Democrats), Dr. med. Peter Liese. "I welcome the fact that independent, scientific experts are now analysing and evaluating the Russian data. As with the other vaccine candidates, the data will be assessed on a purely scientific basis. I do not rule out the possibility that the vaccine will be assessed as effective and can be used in Europe. Anything that helps us fight the pandemic is of course welcome. However, I remain sceptical. The clinical data presented by the Gamaleja Institute on Sputnik V still have a big question mark for me, and the publication in the scientific journal Lancet has raised critical questions.
BioNTech factory in Marburg starts production ahead of schedule
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Success thanks to hard work and not through complaining / Myth: Europe ordered vaccine too late and spent too little money / Not everything is perfect, but others would have more reason to admit mistakes
"That the BioNTech factory in Marburg is brought to service earlier is a great success and a sign that getting down to business is more important than complaining. In the last few months, those responsible at BioNTech as well as representatives of the regional and national German government and the EU have worked hard to make the commissioning possible. In many discussions with BioNTech and the Hessian government, among others, I have tried to add my part as a small contribution. The factory is close to my heart because it is a game changer for Europe in pandemic control and because I once visited it personally during my student days studying medicine in Marburg. The example shows what needs to be done now: The bringing into service was not achieved by complaining towards the pharmaceutical industry or the political leaders in Germany and EU, but by working hard," said the health spokesperson of the largest political group in the European Parliament (EPP, Christian Democrats), Dr med Peter Liese.
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If we all stay reasonable and patient for some more weeks now, spring and summer 2021 will be much better than spring and summer 2020
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Reduce the incidence and then open step by step with more vaccination every day
"If all stay reasonable and patient for some more weeks now, spring and summer 2021 will be much better than spring and summer 2020,” said the spokesman on health of the biggest parliamentary group (EPP, Christian Democrats), Dr. med. Peter Liese. Liese said that the situation in some of the EU member states is still very problematic and one shouldn’t open up the public life too hasty.
“The developments in Ireland, Portugal and Slovakia show what can happen when we don’t have the virus under control,” said Liese. On the other hand, Liese said that he is very optimistic. “When looking at spring, we will have more and more vaccine every week. If we have vaccinated the elderly and the medical stuff and if the weather allows us to be much more outside, we can afford much more without putting another stress test to our health care systems. But we have to be patient for some weeks.” Liese insisted that the member states need to co-ordinate much more when it comes to incoming flights from areas with a high incidence of coronavirus mutants like South Africa and Brazil. Every traveller from these countries should be under strong quarantine and unnecessary flights should be avoided completely. Unfortunately, also border controls inside the European Union are necessary. In Czech Republic, for example, the incidence is very high. A colleague from Czech Republic who is not from EPP, literally said: ‘Babiš messed it up.’ That’s why it’s understandable that neighbour countries react with strict border controls. In this case, I cannot defend the position of the European Commission,” said the doctor and MEP.
Developments in Portugal and Ireland must be a warning to not lift measures too quickly
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Measures for primary schools and students in last year of high school must be better than before Christmas / Allow lifting measures for outdoor activities as the next step
"If we lift he measures too quickly and too comprehensively now, we could see a dramatic explosion in the incidence of infections and a total overload of the health system within four to five weeks. That is why targeted openings are the right thing to do, but we must continue to be very cautious," explained the health spokesperson of the largest political group in the European Parliament (EPP, Christian Democrats), Dr med. Peter Liese, referring to the infection situation in other European countries such as Ireland and Portugal.
"Portugal has a total overload of health care system at the moment and therefore it is good that even the German Armed Forces are helping in Portugal. Until a few weeks ago, the infection figures were quite under control (28 December 2020). However, especially during Christmas, the measures were lifted generously: there were no restrictions on how many people per household one was allowed to meet during Christmas and the nighttime curfew was also shortened. This led to an almost eightfold increase (7.85) in the number of infections within four weeks (28.12.2020: 2,093 to 28.01.2021: 16,432). The spread of the B117 virus variant first detected in the UK has obviously played a role, and possibly also the Brazilian variant (also called V3).
In Ireland, there was an even more dramatic development, but those responsible stopped it early enough through targeted measures. In December, Ireland had the virus under control so well that on some days there were no deaths at all. Additionally, the number of infections was well below 50 in a country of 5 million people with a 7-day incidence of about 250 per day. Nevertheless, already in the beginning of December measures were lifted very generously: gyms, cinemas as well as restaurants were opened and even during Christmas, many more contacts were allowed than in for example Germany. This, in combination with the new British virus variant, which of course mainly entered the Republic of Ireland via the open border with Northern Ireland, has obviously led to an almost twenty-fold increase within 26 days (13.12.2020: 429 to 08.01.2021: 8,227).
Read more: Developments in Portugal and Ireland must be a warning to not lift measures too quickly