At its meeting of 20 April 2021, EMA’s safety committee (PRAC) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen. PRAC 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 associated with low levels of blood platelets, one of which had a fatal outcome. As of 13 April 2021, over 7 million people had received Janssen’s vaccine in the United States.
All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women. Based on the currently available evidence, specific risk factors have not been confirmed.
PRAC noted that the blood clots occurred mostly at unusual sites such as in veins in the brain (cerebral venous sinus thrombosis, CVST) and the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding. The cases reviewed were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca, Vaxzevria.
Health-care professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination.
COVID-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects.
EMA’s scientific assessment underpins the safe and effective use of COVID-19 vaccines. Use of the vaccine during vaccination campaigns at national level will take into account the pandemic situation and vaccine availability in individual Member States.
One plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin called heparin induced thrombocytopenia, HIT.
PRAC emphasizes the importance of prompt specialist medical treatment. By recognising the signs of bloods clots and low blood platelets and treating them early, health-care professionals can help those affected in their recovery and avoid complications. Thrombosis in combination with thrombocytopenia requires specialised clinical management. Healthcare professionals should consult applicable guidance and/or consult specialists (e.g., haematologists, specialists in coagulation) to diagnose and treat this condition.
As for all vaccines, EMA will continue to monitor the vaccine’s safety and effectiveness and provide the public with the latest information.
A similar signal evaluation was recently finalized for another COVID-19 vaccine, Vaxzevria (previously COVID-19 Vaccine AstraZeneca).
Information for the public
- Cases of unusual blood clots with low platelets have occurred in people who received Janssen’s COVID-19 vaccine in the United States.
- The risk of having this side effect is very low, but people who will receive the vaccine should still be aware of symptoms so they can get prompt medical treatment to help recovery and avoid complications.
- Individuals must seek urgent medical attention if they have any of the following symptoms in the three weeks after being vaccinated with COVID-19 Vaccine Janssen:
- Shortness of breath;
- chest pain;
- leg swelling;
- persistent abdominal (belly) pain;
- neurological symptoms, such as severe and persistent headaches or blurred vision, and;
- tiny blood spots under the skin beyond the site of the injection.
- Speak to your healthcare professional or contact your relevant national health authorities if you have any questions about your vaccination.
Information for healthcare professionals
- EMA has reviewed eight cases of thrombosis in combination with thrombocytopenia in people who received Janssen’s COVID-19 vaccine in the United States.
- These very rare types of thrombosis (with thrombocytopenia) included venous thrombosis mostly in unusual sites such as cerebral venous sinus thrombosis and splanchnic vein thrombosis, as well as arterial thrombosis, and fatal outcome in one case. All cases occurred in people below 60 years of age, and most were in women, within three weeks of the person being vaccinated.
- The cases reviewed were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca, Vaxzevria.
- As for the mechanism, it is thought that the vaccine may trigger an immune response leading to a heparin-induced-thrombocytopenia like disorder. At this time, the pathophysiological mechanism has not been established, and it is currently not possible to identify specific risk factors.
- Healthcare professionals should be alert to the signs and symptoms of thromboembolism and thrombocytopenia so that they can promptly treat people affected in line with available guidelines.
- Thrombosis in combination with thrombocytopenia requires specialised clinical management. Healthcare professionals should consult applicable guidance and/or consult specialists (e.g., haematologists, specialists in coagulation) to diagnose and treat this condition.
- Healthcare professionals should tell people receiving the vaccine that they must seek medical attention if they develop:
- symptoms of blood clots such as shortness of breath, chest pain, leg swelling, persistent abdominal pain
- neurological symptoms such as severe and persistent headaches and blurred vision
- petechiae beyond the site of vaccination after a few days.
- The benefits of the vaccine continue to outweigh the risks for people who receive it. The vaccine is effective at preventing COVID-19 and reducing hospitalisations and deaths.
A direct healthcare professional communication (DHPC) will be sent to healthcare professionals involved in giving the vaccine in the EU. The DHPC will also be published.
More about the vaccine
COVID-19 Vaccine Janssen is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. COVID-19 is caused by SARS-CoV-2 virus. COVID-19 Vaccine Janssen is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein from SARS-CoV-2. COVID-19 Vaccine Janssen does not contain the virus itself and cannot cause COVID-19.
The most common side effects with COVID-19 Vaccine Janssen are usually mild or moderate and improve within a few days after vaccination. More information is available.
COVID-19 Vaccine Janssen was authorised in the EU on 11 March 2021; the rollout of the vaccine in the EU was temporarily delayed by the company.
More about the procedure
The review of thromboembolic events with COVID-19 Vaccine Janssen is being carried out in the context of a safety signal, under an accelerated timetable. A safety signal is information on a new or incompletely documented adverse event that is potentially caused by a medicine and that warrants further investigation. The presence of a safety signal does not necessarily mean that a medicine has caused the reported adverse event. The assessment of safety signals seeks to establish whether a causal relationship between the medicine and the adverse event is at least a reasonable possibility.
The review is being carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines. Once the review is completed, PRAC will make further recommendations as necessary to minimise risks and protect patients' health. EMA’s human medicine committee, CHMP, will then rapidly assess any necessary changes to the product information.
EMA’s scientific assessment underpins the safe and effective use of COVID-19 vaccines. EMA’s recommendations are the foundation upon which individual EU member states will design and implement their own national vaccination campaigns. These may differ from country to country depending on their national needs and circumstances, such as infection rates, priority populations, vaccine availability and hospitalization rates.
- COVID-19 Vaccine Janssen: EPAR
- Extraordinary meeting of the Pharmacovigilance Risk Assessment Committee (PRAC): 20 April 2021
- COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues (14/04/2021)
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021 (09/04/2021)
- COVID-19: latest updates
- COVID-19 vaccines: authorised
- Pharmacovigilance Risk Assessment Committee (PRAC)
- Direct health care professional communications
EU has not yet ordered more AstraZeneca vaccines, says internal market commissioner
The European Union has not yet made any new orders for AstraZeneca (AZN.L) vaccines beyond June when their contract ends, European Internal Market Commissioner Thierry Breton (pictured) said on Sunday (9 May).
The Commission last month launched legal action against AstraZeneca for not respecting its contract for the supply of COVID-19 vaccines and for not having a “reliable” plan to ensure timely deliveries.
"We did not renew the order after June. We’ll see what happens," said Breton, adding that it was "a very good vaccine".
Concerns has risen on potential side-effects of the Anglo-Swedish COVID-19 vaccine.
Europe's medicines regulator said on Friday it is reviewing reports of a rare nerve-degenerating disorder in people who received the shots, a move that comes after it found the vaccine may have caused very rare blood clotting cases. Read more.
Breton said an increase in prices for second generation vaccines could be justified by the extra research required and potential changes to industrial equipment.
The European Union signed a new contract with Pfizer-Biontech to receive 1.8 billion doses of COVID-19 vaccines for 2021-2023, to cover booster shots, donations and reselling of doses, the European Commission said on Friday (7 May). Read more.
“There may be a little extra cost but I will let the competent authorities unveil it in due course,” he told France Inter radio.
Hoping to lure back tourists, Greece reopens beaches after lockdown
With widely spaced sun loungers and regular disinfections, Greece reopened its organised beaches on Saturday as the popular Mediterranean holiday destination eases COVID-19 curbs in preparation for the return of foreign visitors this week.
Tourism accounts for about a fifth of Greece's economy and jobs, and - after the worst year on record for the industry last year - the country can ill afford another lost summer. Read more
"We're pinning our hopes on tourism," said Nikos Venieris, who manages a sandy beach in the seafront suburb of Alimos, just outside the capital, Athens, where social distancing measures will remain in place.
"We're one of the places along the Athens riviera ... that receives many tourists so the number of visitors from abroad will play a big role in our finances," he added.
Under current measures, beach managers like Venieris will have to place umbrellas at least four metres (13 feet), carry out regular disinfections and test beach bar employees and other staff for COVID-19.
Greece fared well in keeping the first wave of the pandemic under control last year but a resurgence in cases pushed health services to the limit and prompted authorities to impose a second lockdown in November.
As infections have fallen and vaccinations gathered pace, authorities have steadily eased restrictions, opening bars and restaurants earlier this week.
On Friday, they announced that museums would reopen next week before the lifting of travel restrictions on vaccinated foreign visitors on May 15.
Greek Prime Minister Kyriakos Mitsotakis has said a combination of widespread testing, immunisation, and the fact that many activities would take place outdoors gave authorities confidence that tourists would be able to visit safely.
For Greek beach lovers, Saturday's reopening of the country's largest beaches was a chance to let off steam after months of lockdown.
"We've been longing for this for six months now, because we're winter swimmers and we've really missed it," said Spiros Linardos, a pensioner, reclining on a sun lounger at Alimos.
EU calls on US and others to export their vaccines
The European Commission called on Friday (7 May) on the United States and other major COVID-19 vaccine producers to export what they make as the European Union does, rather than talk about waiving intellectual property rights to the shots.
Commission head Ursula von der Leyen told a news conference on the sidelines of a summit of EU leaders that discussions on the waiver would not produce a single dose of COVID-19 vaccine in the short- to medium-term.
"We should be open to lead this discussion. But when we lead this discussion, there needs to be a 360 degree view on it because we need vaccines now for the whole world," she said.
"The European Union is the only continental or democratic region of this world that is exporting at large scale," von der Leyen said.
She said about 50% of European-produced coronavirus vaccine is exported to almost 90 countries, including those in the World Health Organization-backed COVAX program.
"And we invite all those who engage in the debate of a waiver for IP rights also to join us to commit to be willing to export a large share of what is being produced in that region," she said.
Only higher production, removing exports barriers and the sharing of already-ordered vaccines could immediately help fight the pandemic quickly, she said.
"So what is necessary in the short term and the medium term: First of all vaccine sharing. Secondly export of vaccines that are being produced. And the third is investment in the increasing of the capacity to manufacture vaccines."
Von der Leyen said the European Union had started its vaccine sharing mechanism, citing delivery of 615,000 doses to the Western Balkans as an example.
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