EU approves single-shot Johnson & Johnson vaccine

Company to deliver 200m doses to EU with 600,000 to Republic between April and June

The Johnson & Johnson Janssen Covid-19 vaccine. Photograph: David Ryder/Bloomberg

The Johnson & Johnson Janssen Covid-19 vaccine. Photograph: David Ryder/Bloomberg

 

The European Medicines Agency (EMA) has approved the single-dose Johnson&Johnson Covid-19 vaccine, making it the fourth authorised for use by the bloc.

The company has committed to deliver 200 million doses to the EU this year, with 600,000 pencilled in to arrive in Ireland between April and June. The European Commission also approved the vaccine for use.

The ease of administering the vaccine, which can be stored in an ordinary fridge and requires only one dose, has been flagged as a game-changer but a global scramble for doses is putting pressure on supply chains.

US president Joe Biden has made the Johnson&Johnson jabs a cornerstone of plans to speed up his vaccination rollout and has retained a ban on exporting it, a difficulty for Europea as the US multinational’s supply chain is trans-Atlantic.

Mr Biden has likened the circumstances to a “war”, and indicated that doses could be shared only if the US had a surplus.

French pharmaceutical giant Sanofi has stepped in to provide a factory near Lyon to make doses, where it says it has the capacity to make up to 12 million a month, but the timeline for production is unclear.

The EMA has been reviewing trial data on the vaccine on a rolling basis as it emerged in recent months in an effort to speed up its decision on the vaccine. Further Covid-19 vaccines are also under rolling review but have not yet applied for EU authorisation including Curevac, Novavax and Sputnik V.

Medicines

The EMA also announced it had begun rolling review of the evidence of two medicines for the treatment of Covid-19 for use in combination to prevent the virus entering the body’s cells.

The antibodies, bamlanivimab and etesemivab, are being developed by Eli Lilly. Evidence so far is based on animal studies and it is “too early to draw any conclusions regarding the benefit-risk balance” of the medicines, the EMA said.

Meanwhile, EU controls on vaccine exports that were due to lapse at the end of March will be extended to June, the European Commission announced.

The rule requires pharmaceutical companies that have outstanding deliveries due to EU countries to have permission from national governments to ship doses to certain countries outside the bloc.

A long list of countries are excluded from the controls, including developing and middle-income countries and nations with close ties with the EU. Exports of Pfizer, Moderna or AstraZeneca vaccines bound for the United Kingdom, Canada, Mexico and Australia require a permit, however.

Australia

So far, only one shipment has been refused, of 250,000 vaccine doses for Australia. Since the introduction of the rule at the start of February more than 34 million doses in 249 shipments to 31 countries were approved, according to the commission.

When exports are refused, they are not seized by national authorities: the doses remain the property of the pharmaceutical company, which then makes a decision on what to do with the stock.

The revelation that more tan 8 million doses of vaccines were exported from the EU to the UK in the month of February has fuelled calls for tougher restrictions on exports.