EMA backs J&J's COVID vaccine despite blood clot links
April 20, 2021
The EU's medicines regulator said that the benefits of the Johnson & Johnson coronavirus vaccine outweighed the risks, despite finding possible links to "very rare" cases of blood clots.
The EMA has backed the J&J vaccine, though it does recognize "very rare" cases of blood clotting linked to the shotImage: Dado Ruvic/REUTERS
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The European Medicines Agency (EMA) said Tuesday the Johnson & Johnson (J&J) COVID-19 vaccine has possible links to "very rare" cases of blood clots — but stopped short of ruling against using the one-shot dose.
The EMA said its safety committee had decided that a warning over unusual blood clots would suffice on the labels of J&J's vaccine, just as the health body did for AstraZeneca's doses.
The EU drug regulator said in a statement: "The EMA concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen [the market name for the J&J vaccine]." The EMA "also concluded that these events should be listed as very rare side effects of the vaccine."
"In reaching its conclusion, the Committee took into consideration all currently available evidence including eight reports from the United States of serious cases of unusual blood clots."
Last week, J&J halted its European rollout after the US Food and Drug Administration (USFDA) recommended a pause to administering the shot while rare blood clot cases are investigated.
US health officials identified a very small number of unusual blood clotting disorders among nearly 7 million people who were immunized with the one-dose vaccine across the country.
US decision expected on Friday
Washington's pandemic chief Anthony Fauci said the United States is likely to announce its decision by Friday.
Fauci said he'd be, "very surprised if we don't have a resumption in some form."
Johnson & Johnson advised European governments to store their doses until the EMA had come to a conclusion.
The delay was a further blow to vaccination efforts in the European Union, which have been plagued by logistical problems and concerns over rare instances of blood clots in people who received the AstraZeneca vaccine.
Restrictions on nonessential travel in Europe — country by country
Several European Union member states have announced stricter travel restrictions mandating further tests and extending quarantines to prevent the spread of mutant COVID-19 variants.
Image: Alexander Farnsworth/picture alliance
Poland
The Polish government has begun to ease the recent lockdown rules, although some restrictions remain in place until further notice. Many tourist attractions will open again in the next few days and hotels follow from May 8. Restaurants will be allowed to serve food in outdoor areas from May 15, and indoor dining returns from May 29. Nightclubs, however, remain closed until further notice.
Image: picture-alliance/NurPhoto/A. Widak
Czech Republic
Travel to the Czech Republic for tourist reasons remains prohibited. After more than half a year, all retail stores are permitted to reopen on May 10. Masks may then be removed outdoors if a distance of two meters can be maintained. Restaurants and hotels, meanwhile, remain closed. Outdoor restaurants are to be allowed to open on May 17.
Image: picture alliance/dpa
Finland
The Finnish government decided to extend the restrictions on entry into Finland until May 25. Restaurants are expected to reopen this month with limited seating and opening hours. In June the plan is to lift restrictions on public gatherings and allow travel from most other European countries. Travel for business reasons from outside the EU into Finland may be permitted from July.
Image: Getty Images/AFP/J. Nousiainen
Sweden
Travelers from most EU countries, and people travelling from non-EU countries who are exempted from the EU's entry ban, will have to show a negative COVID-19 test no older than 48 hours on arrival, or be turned away. These rules will apply until May 31. There is a ban on entry to Sweden from the UK, Denmark and Norway, apart from Swedish citizens and people who live or work in Sweden.
Image: Alexander Farnsworth/picture alliance
Denmark
Non-essential tourist travel is still warned against but fully vaccinated people from EU countries ─ including tourists ─ can now enter Denmark. Unlike other travelers, they do not have to show a negative COVID test and they are not subject to testing and quarantine after arrival. Stores are open again in Denmark. Cafés, restaurants and bars are allowed to serve customers outdoors again.
Travelers arriving by air must present a negative test no more than 72 hours old and only arrivals from risk areas have to quarantine. Hotels are open, as are museums, stores, theaters, cinemas, zoos and amusement parks. Food and drink can be served on restaurant terraces. Wearing masks is mandatory everywhere. There are no curfews. There are no special concessions for vaccinated persons.
Image: Imago Images/Geisser
Luxembourg
Travelers from EU and Schengen Area countries can enter Luxembourg without the need to present a negative COVID-19 test unless they arrive by air; since January 29 a negative test must be shown at boarding. Nonessential travel from most third countries is banned. Non-essential shops are open, but bars and restaurants are closed in Luxembourg and there is a curfew from 11 p.m.
Image: imago/alimdi
Norway
Norway’s borders are closed to all but essential travel. A negative COVID-19 test result is required upon, entry while people from some countries have to take a test upon arrival. Everyone who does arrive in Norway has to register and quarantine for ten days. There are quarantine hotels at major entry points. Quarantine can be reduced to 7 days subject to 2 negative tests after arrival.
Image: picture-alliance/robertharding/J. Nix
Turkey
All travelers aged 6 years and above have to show a negative PCR test result before they can enter Turkey and may be subject to health screening when they arrive. A passenger locator form has to be filled out. Until May 17 the country is in full lockdown, meaning residents have to stay indoors except for essential shopping trips and urgent medical treatment.
Image: picture-alliance/R. Hackenberg
Croatia
Croatia is following a traffic light system for travel restrictions and anybody coming from an EU country on the "green list" can enter the country without any restrictions. That's providing they show no symptoms and haven't been in close proximity to an infected person. All other travelers have to show a negative COVID-19 test no older than 48 hours on arrival.
