VIDEOVaccine manufacturer Janssen resumes the supply of corona vaccines to EU countries. European medicine watchdog EMA notes that there may be a link between very rare cases of serious blood clots, but that the benefits of vaccination outweigh the possible side effects. The vaccination with the Janssen vaccine starts tomorrow.
Healthcare minister Hugo de Jonge just announced this during the press conference about the corona measures. “At the bottom of the line, Janssen is a working vaccine, a safe vaccine. The benefits outweigh the risks. In short, prick, ”says De Jonge. He says that resuming injections with the Janssen vaccine will keep the vaccination program on track.
However, a warning should be included in the product information of the vaccine, according to the EMA.
The combination of severe thrombosis and platelet deficiency has been reported eight times in the United States after more than 7 million vaccinations to date. One person died. All side effects occurred in people under 60 years of age, mainly women, within three weeks of vaccination. The EMA cannot identify specific risk factors based on the current evidence, the drug authority reports in a press release.
The blood clots occurred in unusual places, such as in the brain, abdomen, and arteries. This was accompanied by a reduced number of platelets and sometimes bleeding. The reports were very similar to the possible side effects that occurred in people who received the AstraZeneca vaccine, the EMA reports.
That injection is based on the same technique. However, the side effect was reported more frequently with AstraZeneca. Two weeks ago, the EMA had recorded 169 reports of brain thrombosis and 53 reports of abdominal vein thrombosis out of a total of 34 million injections with AstraZeneca.
“The numbers at Janssen are essentially different”, De Jonge concludes. According to him there is also no reason to change the strategy and, for example, no longer prick people under the age of 60 with Janssen. “We do not have any data to say: this could pose a danger to women, the elderly or the young. This is such a limited number of cases, namely 8 from the US based on seven million injections. So we cannot infer much from that ”, says the minister.
Janssen is resuming the supply of corona vaccines to EU countries after EMA’s judgment. The company reiterates that it remains “committed to providing 200 million doses” to the European Union, Norway and Iceland.
The European Commission is calling on EU countries to prick with the Janssen vaccine. They should follow the positive judgment of the European regulator, says EU Commissioner Stella Kyriakides (Public Health). “Vaccinations save lives.”
After this observation, injecting AstraZeneca with 60-year-olds was stopped in the Netherlands, because the complication seemed to occur relatively more often in that group than in the over-60s.
A possible explanation for the occurrence of the complication is a rare immune system response. This immune response is also sometimes seen in patients treated with the drug heparin, which is used to treat or prevent blood clots.
If the complication occurs, serious consequences can be prevented by medical help, the EMA says. Among other things, vaccinees should keep an eye out for minor bruises. Other symptoms include shortness of breath, chest pain, a swollen leg and neurological complaints such as headaches or blurred vision, said Menno Huisman, professor of internal medicine (LUMC) and thrombosis specialist. rather opposite this site. “If the doctors arrive on time, the thrombosis can be treated well with the right anticoagulant. (…) They shouldn’t use heparin. ”
Last week, the first 80,000 doses of the vaccine developed at Janssen Vaccines in Leiden arrived in the Netherlands and the rest of Europe. On the advice of US health authorities to Janssen’s parent company, Johnson & Johnson, the vaccine was being rolled out shut down in Europe. In the United States it was also temporarily stopped injecting Janssen.
The first doses were reserved, among other things for hospital personnel. Unlike other vaccines, a single shot is enough to provide protection. The Netherlands has ordered 11.3 million doses of the vaccine.
Three million injections should be delivered before the end of June. The vaccine therefore plays an important role in the ambition to give every adult who wants it at least one vaccination before the beginning of July. If, on the basis of the EMA’s opinion, the cabinet decides to only give the vaccine to people over 60, just as with AstraZeneca, that ambition could be thrown away.
“The serious blood clotting problems appear as a side effect and as a warning in the package leaflet and product information”, says Ton de Boer of the Dutch Medicines Evaluation Board, which has a place on the EMA side effects committee on behalf of the Netherlands. response. “It is now up to Minister De Jonge to decide to what extent this will have consequences for the vaccination campaign. At national level, other factors are taken into account in a decision: such as the availability of other corona vaccines and the epidemiological situation in the country concerned.”