Up to now, the EU has used its new export control rules mechanism only once, denying AstraZeneca permission to ship 250,000 doses from Italy to Australia, but the European Commission now suggests that the time has come to protect the bloc’s dwindling stockpile. 

Beyond the current export restrictions, one avenue supposedly being opened is invoking Article 122 of the EU treaty to keep vaccines made in member states from being shipped elsewhere. Similar to the US Defense Production Act, this would allow restrictions in case of “severe difficulties in the supply of certain products.” In addition to blocking exports, officials could waive patents and intellectual property rights on vaccines, a move sure to be unpopular with manufacturers.

Commission president Ursula von der Leyen said 41 million vaccine doses have been exported by manufacturers from EU production sites to 33 countries in six weeks, with more than 10 million of the total going to the UK. This, she said, accounted for more than the total number of shots administered in the ex-member state in February and over a third of the total number of UK vaccinations so far.

EU figures show that as of 11 March, 3.9 million doses had been shipped from the EU to Canada, and 3.1 million to Mexico. Around 1 million doses are said to have gone to the US, which has ordered close to 1 billion vaccine doses, including the not yet approved AstraZeneca shot. Some of the doses are being produced in the US by domestic and foreign CDMOs.

US president Joe Biden has said he plans to talk with heads of state in other countries about redistributing any surplus doses. Mexico has inquired about taking US doses of AstraZeneca’s product that are sitting in storage while the FDA continues to study the company’s data. Separately, AstraZeneca is seen as having asked Washington to free up some of the doses for Europe, to no avail.

According to UK state broadcaster BBC, the British government has made no official mention of any vaccine exports nor confirmed that any have taken place. It said prime minister Boris Johnson told the House of Commons recently that the country also “has not blocked the export of a single Covid-19 vaccine or vaccine components.”

While BBC said “publicly available information suggests vaccines are not being exported from the UK,” it recalled remarks by AstraZeneca CEO Pascal Soriot that the company's contract with London assumes the government will have the highest priority. The heads of both the US and the UK have stressed that while their first priority is to inoculate their own populations, they are helping to fund the Covax initiative that distributes vaccines to poorer countries.

In response to von der Leyen’s claims that AstraZeneca has fallen short on its supply commitment to the EU while diverting doses across the channel, health secretary Matt Hancock replied that the UK government had contracted for delivery of the first 100 million doses of the company’s shot and that the company’s EU production facilities were simply fulfilling contractual responsibilities.

The threat of export restrictions could loom over vaccine makers and their CDMO partners more severely in the second quarter when, instead of an expected surplus, country leaders find that their supplies are dwindling. After cutting its commitments to Europe, AstraZeneca could find itself reneging on a promise to the UK even without European export controls, reports suggest.

US biotech Moderna is due to deliver “a few hundred thousand” doses in April, BBC said, but the UK could receive 20% fewer vials than promised as CDMO Lonza tries to scale up production at its Visp site in Switzerland. Elsewhere, Catalent is planning to expand output at its fill & finish plant in Anagni, Italy to produce Johnson & Johnson’s single-shot coronavirus vaccine but this is thought unlikely to start up before the fourth quarter.

The British vaccine task force has reportedly warned the National Health Service that there could be a “significant reduction” in weekly deliveries from manufacturers starting the week of Mar. 29, due to “reductions in national inbound vaccines supply.” The need for second doses is expected to double from the beginning of April, the officials noted. 

According to an analysis by Financial Times, the UK will need to deliver a minimum of 2 million shots per week throughout April to be able to delivering second doses 11 weeks after the first. The paper said vaccine supplies will increase up to the end of March, when people aged 50 and older are due to receive their first doses. After that, having to delay vaccinations for those younger could upend plans to ease nationwide lockdown restrictions.

In contrast to some other countries, the UK is stretching intervals between doses to assure that as many people as possible receive at least one shot. It has even considered delaying the second dose indefinitely, as some studies have shown a single shot to be sufficiently effective to slow infections. Manufacturers of mRNA drugs and virologists, some of them British, have urged that all follow their recommendations of spacing shots two to three weeks apart.

Pfizer/BioNTech meanwhile have agree to move up delivery of 10 million dose of their vaccine from the third or fourth quarter to the second quarter to fill the expected supply gaps. The deal must still be approved by member states.

Author: Dede Williams, Freelance Journalist