J&J’s Single Shot Is EU’s Fourth COVID-19 Vaccine – But Supplies Lag

The arrival of another vaccine is welcome news for Europe’s stuttering COVID-19 vaccination program, but it will be weeks before J&J’s production is up to speed.

Development of the vaccine was led by the company's Janssen division in Leiden, Netherlands.

The European Union has granted conditional marketing authorization to a fourth COVID-19 vaccine, Johnson & Johnson’s Ad26.COV2.S.

The single-dose vaccine will boost overall supplies and help the EU towards its goal of having all adults vaccinated by the end of summer – but Europeans will have to wait another month before the first doses are available for administration.

That is because J&J's Janssen vaccines and pharma division, like all other frontrunners in the COVID-19 vaccine race, has had to scale up massively its manufacturing network over the past 12 months, and is struggling to meet demand. 

200 million doses of the vaccine will be supplied to the EU, Norway and Iceland this year. J&J has agreed to supply 55 million doses in the second quarter, something it has confirmed it will still achieve, starting with the first batches delivered in late April. 

Nevertheless, there is concern within the European Commission that J&J could struggle to supply the ten of millions of doses pledged by the end of June.

A commission official told Reuters that difficulties with vaccine equipment and components were "putting pressure" on these timelines.

Sanofi Lends A Hand

J&J struck a deal with Sanofi last month to provide capacity in its established infrastructure, made possible by the fact that Sanofi’s own vaccine has been delayed. The French pharma company is making available its vaccine manufacturing plant in Marcy l’Etoile to formulate and fill vials of Janssen’s vaccine at a rate of approximately 12 million doses per month.

J&J aims to have an end-to-end integrated European manufacturing network in place by June, as part of a global manufacturing supply chain.

While there are concerns about supplies of the vaccine, the European Medicine Agency’s Committee for Medicinal Products Human Use (CHMP) raised no issues about its safety and efficacy, in line with the US Food and Drug Administration, which issued an emergency use authorization for the vaccine two weeks ago.

The EU conditional approval was based on data from the Phase III ENSEMBLE study, which showed that the vaccine was well tolerated and demonstrated a 67% reduction in symptomatic COVID-19 disease in participants who received the vaccine compared with placebo.

The data also demonstrated that the vaccine was 85% effective in preventing severe disease across all regions studied, and that it showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.

J&J has said it is committed to making its COVID-19 vaccine available on a not-for profit basis for emergency pandemic use. As part of this pledge, the company will supply the global COVAX Facility with 500 million doses, beginning in the second half of 2021 and moving into 2022. (Also see "When A Single Shot Is A Problem: J&J’s Study Of Two Doses Raises Equality, Distribution Questions" - Pink Sheet, 1 Mar, 2021.)

AstraZeneca Safety Doubts

The arrival of the vaccine doses should help to accelerate the EU's vaccination program speed, which has so far lagged far behind comparable nations such as the UK and US, and has been bedeviled by a number of problems, especially supply issues and efficacy concerns around AstraZeneca's vaccine.

But the J&J approval coincides with more doubts around the AstraZeneca product, which has been suspended in a number of EU member states, including Denmark and Austria, after reports of blood clots and one death. 

The EMA released a statement saying that there was no indication that the vaccination was linked to thromboembolic events. It stated that the number of thromboembolic events in vaccinated people is no higher than the number seen in the general population. As of 10 March, it said 30 cases of thromboembolic events had been reported among close to five million people vaccinated with AstraZeneca's vaccine in the European Economic Area. (Also see "Coronavirus Notebook: AZ Vaccine Suspended In Some European Countries, Janssen’s Vaccine Approved In EU" - Pink Sheet, 12 Mar, 2021.)