03.12.21

EU Greenlights J&J’s Coronavirus Vaccine

Source: FirstWord

The European Commission granted a conditional marketing authorization for Johnson & Johnson’s single-dose COVID-19 vaccine Ad26.COV2.S in people 18 years of age and over. The decision comes just hours after the European Medicines Agency (EMA) gave its backing following a review of “robust” vaccine data that showed Ad26.COV2.S met the criteria for efficacy, safety and quality. It also comes on the heels of an emergency-use authorization granted by the FDA late last month.

Johnson & Johnson’s filing is based on results from the global phase 3 ENSEMBLE trial of nearly 44,000 participants randomized to receive Ad26.COV2.S or placebo. An efficacy rate of about 67% overall was calculated based on 116 cases of symptomatic moderate-to-severe COVID-19 in the vaccinated group 2 weeks after administration, and 348 cases among unvaccinated individuals. Effectiveness varied by region, ranging from 72% in the US to 57% in South Africa, where the highly transmissible B.1.3.5 strain was predominant, while Latin America fell in between at 66%. However, the data showed that when it came to preventing severe disease, Ad26.COV2.S was 85% effective across all regions studied, a result that was highlighted by FDA staff reviewers before the vaccine was greenlighted in the US.

Supply concerns linger

Ursula von der Leyen, president of the European Commission, noted that Ad26.COV2.S “is the fourth authorized vaccine of the EU’s portfolio,” after Pfizer and BioNTech’s Comirnaty, Moderna’s mRNA-1273, and AstraZeneca’s AZD1222, “and will help us enhance the vaccination campaign in the second quarter of 2021.” She added “it only requires a single dose, which takes us another step closer to achieving our collective goal of vaccinating 70% of the adult population by the end of summer.”

Despite the authorisation, questions persist about how quickly Johnson & Johnson will start delivering vaccines on a large scale, following manufacturing problems in the US. According to one report, Johnson & Johnson recently told the EU it is facing supply issues that may hamper plans to deliver 55 million doses of its vaccine to the region in the second quarter, although EU officials have said they would get a fuller picture after the EMA’s approval decision.

The EU has pre-ordered 200 million doses of Johnson & Johnson’s vaccine this year, with an option to buy another 200 million. The company indicated last week that it was confident it would meet its full-year target to the region. To overcome manufacturing difficulties, the US government recently brokered a deal between Johnson & Johnson and Merck & Co., with the latter agreeing to use some of its facilities to help produce Ad26.COV2.S.

US, EU talks to ensure flow of vaccine materials

Meanwhile, the EU and the US started discussions this week on ensuring that neither blocks critical vaccine components from export to each other. An executive order by US President Joe Biden last month raised concerns in Europe that some vaccine materials, potentially affecting Johnson & Johnson doses intended for the EU, could be barred from US export. However, the White House sought to dispel those concerns this week, with an administration expert on exports saying “all vaccine manufacturers in the US are free to export their products, while also fulfilling the terms of their contracts with the US government.”

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