Janssen reactivates vaccine delivery in EU after EMA backing

BrusselsEverything is ready for the EU to start administering the Janssen vaccine. The American drugmaker Johnson&Johnson (Janssen in its European subsidiary) has announced that it is reactivating deliveries of its vaccine to the EU, shortly after the European Medicines Agency (EMA) gave it its backing. The regulator concluded the drug is safe despite the fact that possible "very rare" cases of thrombosis must be included among its side effects. This is exactly the same verdict that the European regulator issued with the AstraZeneca vaccine, with the difference that this time the cases of thrombosis analysed come from the United States, since the Janssen doses had not yet begun to be administered in Europe. Thus, the EMA is again clear that there is a much greater chance of being hospitalised or dying from coronavirus than from thrombosis very rarely caused by the AstraZeneca or Janssen vaccines. It is now up to European governments to decide whether, how and when they resume vaccination.

Spain took no time to react. The Minister of Health, Carolina Darias, appeared before the Senate, where she said she would activate reception and distribution of vaccines as soon as she left the chamber. "This Minister will no waste a single second. Once I finish here, I will go to receive the vaccine and we will be able to distribute them. This Minister is here 24/7. Vaccination, vaccination, vaccination" was Darias's message to the Senate, when it transpired that the company had lifted its recommendation against using its vaccine.

The EMA began looking into the possible link between four cases of severe thrombosis detected in the United States in early April, after similar cases occurred following vaccination with AstraZeneca in Europe. But while the European regulator's experts were studying the data, the pharmaceutical company Johnson & Johnson announced that it was unilaterally halting distribution of its doses in Europe after the US regulator recommended stopping its use in the United States because of six cases of thrombosis among 7 million vaccinated people.

The cases tested for the Janssen vaccine all occurred in people under the age of 60 who had received the vaccine less than three weeks before, most of them women. Even so, the EMA insists that so far the available evidence does not show that "there are specific risk factors" such as gender or age. "The cases reviewed were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca," the EMA statement said.

Brussels urges governments to use the vaccine

The company's decision to halt the distribution of doses in Europe came the day after it began shipping doses to different European countries. For example, Spain received 146,000, which had been stored pending a decision by the EMA. However, now the EMA has published its verdict, everything is ready for the campaign to resume. This Tuesday the pharmaceutical announced in a statement that it is resuming delivery and that it will update its leaflet to include information about the "very rare" negative side effects related with thrombosis.

The EU's Health Comissioner, Stella Kyriakides, was also very quick to respond. In a tweet, she urged EU governments to start using the vaccine as soon as possible. However, governments are free to establish their own criteria for the administration of the vaccine. In the case of AstraZeneca, criteria as to which age bands the vaccine should be administered to have varied widely: while Denmark has banned its use outright, other countries such as Spain have limited its administration to certain age bands (in Spain, only those between 60 and 69 can receive the AstraZeneca jab).

What the vaccines of Janssen, AstraZeneca and also Sputnik have in common is the use of an adenovirus which, as explained by infectologist Oriol Mitjà in an interview with ARA, "in some cases could drive platelets crazy and cause thrombi". According to this expert, this "very rare" side effect can be treated if a protocol and appropriate treatments are established. In the case of AstraZeneca, the EMA has already reiterated that the vaccine is "safe and effective" because the benefits far outweigh the risks despite the fact that in "very rare" cases it can cause thrombosis.

The importance of the unique single-dose vaccine

The halt in the distribution of Janssen's doses was a new major stumbling block in the European vaccination strategy, disrupted by AstraZeneca's repeated failures. Janssen's vaccine, the only single-dose vaccine currently licensed in Europe, was given the green light by the European regulator on 11 March and was due to begin distribution a week ago. The delivery commitment is 400 million doses of Johnson & Johnson, of which 55 were to arrive in the second quarter of the year.

But in light of the stumbling blocks with both AstraZeneca and Janssen, the European Commission is throwing itself into Pfizer/BioNTech's hands. "It is a reliable partner," said the president of the EU executive last week when she announced negotiations for a new contract with the American pharmaceutical company for 2022. In addition, on Monday, the Commissioner for Health, Stella Kyriakides, announced the purchase of 100 million more Pfizer doses this year, which will increase to 600 million the number of vaccines that this company will have to deliver to the EU in 2021.