EU gives green light to Janssen vaccine but distribution problems persist

The European Medicines Agency (EMA) has recommended this Thursday the authorization of the vaccine developed by the Janssen laboratory, the fourth that may reach the European market after those of BioNTech-Pfizer, Moderna and AstraZeneca, and the first of a single dose.

The European Commission, predictably, will complete the green light in a matter of hours and it is expected that the first vials of the new vaccine will begin to be distributed in April.

Janssen (the pharmaceutical subsidiary of the US group Johnson & Johnson) requested the assessment of the EMA on February 16 and the examination has been carried out through an accelerated procedure.

The recommendation to authorize the conditional marketing of the new vaccine took place during a virtual meeting of the Committee for Medicinal Products for Human Use (CHMP) of the EMA.

The vaccine has been shown to be 67% effective in a clinical trial conducted with 44,000 people over 18 years of age in the United States, South Africa and Latin America.

That is, after two weeks, there was a 67% reduction in the number of symptomatic cases of covid in subjects who had received the drug compared to those who had received the placebo, explains the regulator.

It is a traditional type vaccine, such as AstraZeneca's, in which a virus is inoculated that incorporates a SARS-CoV-2 gene, the virus that causes covid-19, and thus prepares the immune system to repel future contagions.

Those from Pfizer-BioNTech and Moderna are based on the technology known as messenger RNA, which places this molecule in cells with the genetic instructions necessary to generate natural defenses against SARS-CoV-2.

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The European Commission has a reserve contract with Johnson & Johnson (J&J) for up to 400 million doses, available to all 27 Member States in proportion to their population.

As in the previous cases, the community body only pays the reserve, while each State pays the final bill based on the number of vials it decides to buy.

Brussels has high hopes for the J&J vaccine because it only requires one dose and is easy to transport and store.

All of this could help speed up vaccination campaigns, which are proceeding at a slower pace than anticipated.

Since the start on December 27, only 3.5% of the European population has received the two doses of the vaccines available on the market.

And less than 10% have received the first dose compared to 27% in the United States.

Production problems, especially in the case of AstraZeneca, have contributed to the fact that the most populous countries in the Union (Germany, France, Italy and Spain) have so far received less than 15 doses per 100 inhabitants, according to the data. of the European Center for Disease Prevention and Control (ECDC).

In total, just over 55 million doses have been distributed, less than half of what was expected.

Brussels expected that up to 380 million would be distributed in the second quarter, but pharmaceutical companies have already lowered those expectations to 300 million and they could be even less.

Surprises in production

But Janssen's production could also bring surprises.

The company has already communicated to the European Commission that it may not be able to meet its target of delivering 55 million doses between April and June, Reuters reported this week.

"Unfortunately, J&J will not start shipping immediately after receiving authorization, as it did, for example, with BioNTech-Pfizer in December," laments Peter Liese, German MEP from the Popular group.

"They have production problems, while in the United States they have already started shipping," adds Liese.

In addition, the prime ministers of four European countries (Austria, Denmark, Greece and the Czech Republic) last month addressed the president of the European Commission, Ursula von der Leyen, to warn that the final phase of production of the vaccines of J&J may have to be made in the United States, which would jeopardize its forwarding to Europe given Washington's ban on exporting covid-19 vaccines.

Von der Leyen has already created a working group, headed by the European Commissioner for the Internal Market, Thierry Breton, in charge of negotiating with Washington the necessary measures to guarantee the fluidity of the supply chain, not only of the final product but also of the raw materials necessary for the production of vaccines.

To the setbacks in production has been added the slow administration in some countries of the vaccines received.

25% or more of the available doses are still not injected in 10 of the 27 EU partners (Germany, Belgium, Slovakia, Slovenia, France, Hungary, Ireland, Luxembourg, the Netherlands and Sweden), according to data from the ECDC.

In the case of the AstraZeneca vaccine, between Germany and France alone there are more than two million uninjected doses.

Organizational and logistical failures or the mistrust of public opinion have weighed down some campaigns that aspired to have vaccinated 80% of the population over 80 years old and 80% of the most exposed professions in March.

And before the end of summer, to 70% of the adult population.

The European Commission insists that these are achievable objectives, but doubts do not stop growing.

More vaccines

After the four vaccines authorized so far, the EMA is already reviewing another three: Novavax and Curevac, which are also part of the reserve portfolio negotiated by the European Commission, and the Russian Sputnik V. The Commission reserved up to 2,600 million doses of potential vaccines with six pharmaceutical companies.

With the four authorized so far, the reserve amounts to 1,860 million.

De Curevac, pending authorization, has reserved 405 million.

And with Novavax, for the moment, the negotiations have not been closed.

The Russian vaccine is not part of the community portfolio, but Hungary and Slovakia have allowed its use in their own territories through an emergency authorization.

Sputnik, however, is hardly used at the moment.

Hungary has received 146,000 doses, but has only used 22,000, compared to more than 770,000 from BioNTech, according to ECDC data.

Slovakia, according to the same source, has not had any Russian vaccines yet.

Propaganda weapon

Brussels accuses Russia and China of using their vaccines as geostrategic propaganda weapons despite the difficulties they have for their production, in the first case, and for their distribution.

"We must not be confused by China and Russia," said the President of the European Council, Charles Michel, on Tuesday.

"They organize highly publicized supply operations to other [countries]," Michel noted, but both countries "have administered half the dose of the EU per 100 inhabitants, according to available figures."

Moscow has been seeking alliances with Western pharmaceutical companies for months to be able to increase the production of Sputnik V, developed by the Gamaleya Epidemiological Institute (a public center).

The EMA began the review of the Russian vaccine on March 4 after a request for authorization submitted by the German company R-Pharm.

And this Tuesday, an agreement was made public between the Russian Direct Investment Fund (RDIF), the sovereign fund that has financed the vaccine, with the Swiss company Adienne to start producing the drug in Italy from the third quarter.

The RDIF also announced contacts with companies in other European countries, including Spain, where it negotiates with the investment group IberAtlantic and with the Galician biopharmaceutical company Zendal.