EU: Johnson & Johnson vaccine rollout resumes with labeled warning

On Tuesday US drugmaker Johnson & Johnson confirmed it will resume rollout of the Covid-19 vaccine across Europe after medical regulators across the region confirmed that the benefits of taking the shot outweigh the rare risk of potentially fatal blood clots. This after the US, EU, and South Africa halted the issuing of the J&J jab due to instances of rare blood clotting. 

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The block’s drug regulator, European Medicines Agency (EMA),  listed blood clots as a ‘very rare’ side effect of the J&J vaccine. In a statement, the medical body recommended adding a warning on the possibility of rare blood clots to those with a low blood platelet count. The warning will feature on the vaccine’s product label. Cases of blood clotting in the US was recorded in people below the age of 60 a few weeks after vaccination - most being women. 

Another explanation for the incidence of blood clots and low blood platelets is the immune system response which can be likened to heparin-induced thrombocytopenia, HIT. 

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The use of the J&J vaccine was halted by US regulators after an incidence of a rare brain blood clot and a low blood platelet count were reported among six women prompted the company to delay its rollout across Europe. Over 8 million people across the United States have received the J&J vaccine, 7 of whom have registered the rare blood clot. At the moment, the use of the vaccine across the US remains on hold until the CDC meets for a second time on Friday to determine whether they should lift the pause on the vaccine’s use. J&J can be stored at normal refrigeration temperatures and expected to be widely adopted globally. Similar rare cases of blood clots were also reported with the AstraZeneca Covid-19 vaccine. A loss in public confidence in the vaccine will be counterproductive given it requires taking a single shot, unlike the Pfizer or Moderna jabs.

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In early April, the EMA arrived at a similar conclusion for the AstraZeneca vaccine after recording 86 cases of the unusual blood clot after 86 million jabs were administered. The UK halted issuing the  AstraZeneca vaccine to people below 30 years. 

A blood clot

The chances of developing blood clots from the vaccine are extremely low while the risks from a Covid-19 infection are way higher. As a precaution, the EMA is urging the public to look out for symptoms of blood clotting when taking the J&J vaccine. Chest pains, shortness of breath, abdominal pain, persistent headaches, blurred vision, and leg swelling. If someone develops any of these symptoms three weeks after getting the jab, they should seek urgent medical attention. 

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Following the EMA verdict, the Netherlands will immediately distribute the 80,000 doses of J&J in its stock, where the first Jansen vaccination took place in Leiden, last  Wednesday. The AU recently made an acquisition of 400M doses of the Johnson & Johnson vaccine. South Africa’s health regulator has also given the green light for the vaccine's continued use.