BRUSSELS (Sputnik) – As the European Union grapples with vaccine shortages and member states look for alliances outside the bloc to ramp up production, the European Medicines Agency (EMA) has finally launched a review of Russia’s Sputnik V coronavirus vaccine, which has just overtaken Pfizer as number 2 in terms of regulatory approvals.
On Thursday, EMA announced that it had started a rolling review to test the Russian vaccine for compliance with EU standards for effectiveness, safety and quality.
The developer, Moscow-based Gamaleya research institute, has earlier developed two vaccines against Ebola virus.
The applicant for license production of the Sputnik V vaccine is R-Pharm Germany GmbH. Actually, it was one of the conditions set by Europe that vaccines should be produced in the bloc.
The shift comes two months after German Chancellor Angela Merkel declared after a call with President Vladimir Putin on January 5 that she was open to the idea of bilateral cooperation with Russia for the purpose of tapping European production capacities for the Sputnik V vaccine.
The German cabinet later specified on multiple occasions that this would only happen if the EMA green-lighted the vaccine.
In early February, the prestigious Lancet medical magazine published a study, confirming the vaccine efficacy at 91.6 percent. But it is only now that the EMA embarked on the review.
Approved in 45 countries, the Russian vaccine, meanwhile, has become the world’s second most popular coronavirus vaccine, overtaking Pfizer (43) but still lagging behind AstraZeneca (49), Sputnik V’s Twitter announced on Friday.
EMA Starts Review. Reluctantly?
“EMA will evaluate data as they become available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for formal marketing authorisation application. EMA will assess Sputnik V’s compliance with the usual EU standards for effectiveness, safety and quality,” Thursday’s statement read.
The regulator noted that the evaluation of the Russian vaccine “should take less time than normal,” adding that it is still impossible to “predict the overall timelines.”
A rolling review is de facto a tool to speed up assessment of a promising medicine during a public health emergency.
“Normally, all data on a medicine or vaccine’s effectiveness, safety and quality and all required documents must be ready at the start of the evaluation in a formal application for marketing authorisation. In the case of a rolling review, EMA’s human medicines committee (CHMP) reviews data as they become available from ongoing studies. Once the CHMP decides that sufficient data are available, the company can submit a formal application. By reviewing the data as they become available, the CHMP can come to an opinion on the medicine’s authorisation sooner,” the regulator explained.
To put this in perspective, it is good to remember that European Commission President Ursula von der Leyen wondered back in February “why Russia is offering, theoretically, millions and millions of doses while not sufficiently progressing in vaccinating its own people.”
Brussels still remains very suspicious of Russian and Chinese vaccines, fearing that Moscow and Beijing will try to use it as a tool to extend their influence in the bloc.
Amid Vaccination Mess, EU Nations Strike Alliance With Israel
Frustrated by vaccine delivery delays, several EU member states and accession countries have decided to turn to Moscow and Beijing to get shots, undermining the bloc’s strategy.
Hungary is already vaccinating its population with the Russian vaccine without waiting for European deliveries or an EMA approval. Slovakia is following suit. The Czech Republic is next. Chinese vaccines are also being used.
Austria and Denmark, meanwhile, decided to join forces with Israel on Thursday to create a joint COVID-19 vaccine research and development fund.
That Austria and Denmark play their own score is hardly a surprise in Brussels. Austrian Chancellor Sebastian Kurz and Danish Prime Minister Mette Frederiksen have been worried about late deliveries and slow approvals for months. Earlier this week, Kurz said his country should “no longer depend solely on the EU for the production of vaccines.” They chose Israel, “the first country in the world to demonstrate that the virus can be beaten,” Kurz argued.
Roman Haider, a European Parliament member from Austria’s right-wing Freedom Party, expressed understanding for the move.
“That the citizens of the Member States of the EU cannot rely on the EU in matters of COVID vaccines is shown by the much too late review of the Russian vaccine Sputnik V. While countries such as Serbia but also EU states such as Slovakia have secured the Russian vaccine, the EMA has only now put aside its hesitant behaviour. This shows once again the incompetence of the EU and that Brussels seems to be more interested in political wrangling than in fighting the pandemic,” Haider told Sputnik.
The EU, however, appears to be ill at ease over the Austrian-Danish initiative.
“The Danish-Austrian project is at the level of the ‘idea to be developed’ and does not reflect hard facts, like where this new Israeli vaccine could be produced in the EU. It would probably not be possible in Austria or Denmark. Austria has not been very involved in the other grouped purchasing contracts. It reflects frustration at the slow start of vaccination rather than reality. Some leaders want to show that they do their best to find vaccine doses anywhere and put useless political pressure on Brussels. It is counterproductive,” a diplomat in the European Council, who has been involved in some of vaccine negotiations, told Sputnik on condition of anonymity.
Hungarian Prime Minister Viktor Orban, the official went on, has emerged as a “winner” from this game.”
He was expelled this week from his European party, the EPP and is welcome with open arms by the populists and the conservatives. And at the same time he can boast of a successful vaccination campaign with the Russian and Chinese doses. It is a sweet revenge for him on the European Commission,” the diplomat added.
Europeans Bracing for Extended Lockdowns
For now, March is expected to be very long and boring in Europe, mostly in partial or total lockdown. Member states will have to deal with still insufficient vaccine delivery volumes. The goal is therefore to hold on and remain as united as possible.
Public fatigue from lockdown extensions meanwhile continues to grow, including in Germany.
“The renewed extension of the lockdown until the end of March is an arbitrary act of the Merkel government. The real facts and figures do not provide a reasonable justification for this. The Chancellor and Prime Minister still fail to provide evidence or a valid justification for the alleged ‘necessity’ of the lockdown. The few easing measures announced are completely inadequate,” Alexander Gauland, a co-chairman of the AfD parliamentary group in the German Bundestag, told Sputnik.
The lawmaker also slams the EU’s centralized vaccine distribution as a “disaster.”
“The vaccine alliance that Austria and Denmark now want to enter into with Israel is a wake-up call. Health care is and must remain a national responsibility,” the politician argued.