Under pressure to boost vaccine supplies in the EU, the European Medicines Agency has announced it will start a review of Russia’s Sputnik V product.
The EMA said it has started a “rolling review” of the vaccine to speed up its possible authorization. Such reviews allow the EU agency’s medicines committee to assess data as it becomes available from ongoing studies. Once the committee decides it has sufficient data, the developer of the vaccine can submit a formal application.
On Thursday, Italy highlighted the dire shortages of vaccines in the EU by blocking a shipment of 250,000 AstraZeneca doses to Australia. The vaccines were made at an AstraZeneca plant in Italy.
The export ban marked the first of its kind since the EU adopted a new vaccine export regime in late January. It was put in place after AstraZeneca revealed an enormous shortfall in its vaccine deliveries to the EU, angering governments. Italian Prime Minister Mario Draghi recently said that the EU was not being strict enough on exports as the bloc’s own supplies come up short.
The EMA declined to commit to an approval timeline for the Russian product and other vaccines. The agency has been criticized by some EU leaders, including Austrian Chancellor Sebastian Kurz, for its laggardly approval process.
Several member countries have broken ranks with the EU in recent days, announcing that they will no longer rely exclusively on EMA-approved vaccines. Their frustration stems from the fact the EU’s vaccine rollout remains far behind that of countries such as Britain, the United States, Israel and the United Arab Emirates. At last count, the 27-country EU had administered eight doses per 100 citizens – one-third the U.S. rate and one-quarter the U.K. rate.
Slovakia and Hungary recently bypassed the EMA to grant emergency approval for the Sputnik V vaccine. Denmark and Austria also delivered a rebuke to the EU’s vaccination program by agreeing to hold talks with Israel to produce second-generation vaccines targeting the new, more contagious COVID-19 variants sweeping through dozens of countries.
The Russian product was initially met with skepticism in the EU and elsewhere because it was cleared for use as the world’s first pandemic vaccine even before Phase 3 clinical trials had been completed. It was developed by the state-owned Gamaleya National Centre of Epidemiology and Microbiology and is being marketed internationally by the Russian Direct Investment Fund (RDIF), the country’s sovereign wealth fund.
Skepticism about its safety and effectiveness diminished somewhat last month when The Lancet medical journal published peer-reviewed results of interim trials that showed almost 92-per-cent efficacy. At the same time, German Chancellor Angela Merkel said the Sputnik V vaccine could be used in the EU as long as it received EMA approval.
The application process with the EMA got off to a rocky start. Russia said it formally applied in late January, which was news to the EMA. On Feb. 10, the EMA said it had seen no such application. The RDIF later said it had sent the application to the Heads of Medicines Agencies, a European network that does not approve drugs.
In a statement, RDIF chief executive officer Kirill Dmitriev said, “Following EMA approval, we would be able to provide vaccine for 50 million Europeans starting from June.”
Until Slovakia broke ranks with the EU, the European Commission, the executive arm of the EU, had been the sole buyer of vaccines for the bloc. It argued it could use mass purchasing power to get the best prices and also ensure that each country got fair and equal access to supplies. But the EC moved slowly, allowing Britain and other countries to sign contracts for the first deliveries.
Sputnik V has been approved in 42 countries. Austria and the Czech Republic are reportedly considering buying it, and other EU countries may follow as virus variants pick up momentum, making health authorities desperate for new supplies.
In Italy, the British, Brazilian and South African variants now make up well more than half of new COVID-19 cases. Hot spots, including Bologna, are going back into lockdown.
Sign up for the Coronavirus Update newsletter to read the day’s essential coronavirus news, features and explainers written by Globe reporters and editors.