Is there an export ban on coronavirus vaccines in the US?
There is no formal export ban on vaccines or vaccine components, like syringes, vials and filters. Companies manufacturing vaccines, or items needed by jab makers elsewhere in the world, are free to export them.
However, Washington has used a wartime power known as the Defense Production Act to compel private companies to fulfil its contracts ahead of other orders. This has prompted manufacturers elsewhere in the world, like the Serum Institute in India, to complain of not being able to buy items they would normally import from the US. In normal times, the US is the top global exporter of syringes and needles, according to the OECD.
US officials have defended their use of the DPA. “Making vaccines requires a great deal of specialised materials, and there’s just not enough to go around,” one administration official said this week. “There’s just more global manufacturing happening everywhere in the world than suppliers can currently support.”
Separately, the US has a large stockpile of Oxford/AstraZeneca vaccine doses it bought up early in the development process. Until recently, it rebuffed requests from other countries to share those jabs.
So why has the US exported so few doses?
Joe Biden’s administration had said it would not send vaccines to other parts of the world until there was a plentiful supply in the US, and that its focus was on getting shots into US arms.
Biden said during his speech to Congress on Wednesday: “We will become an arsenal for vaccines for other countries, just as America is an arsenal for democracy for the world . . . [But] every American will have access before that.”
As supply has increased, the administration has come under pressure to share some of its stockpile, especially of AstraZeneca vaccines, which are yet to be approved in the US. But some in the administration worry that they will need more doses in the future to combat new strains or to deliver annual booster shots.
What is the impact of the Defense Production Act?
The DPA has been used dozens of times to make sure manufacturers prioritise medical equipment needed to combat the pandemic. N95 masks, gowns, syringes and vials have all been procured under DPA terms, which allow the government to dictate which domestic contracts should be fulfilled first.
One consequence of this is that pharmaceutical companies have warned hospitals to expect shortages of certain drugs later in the year as the equipment normally used to produce them has been diverted to making equipment and drugs to fight Covid-19.
The DPA does not allow the administration to block exports overseas however, and officials said that foreign vaccine makers are finding it hard to source ingredients simply because global demand is so high. As a result, the Biden administration said this week it would send its own supplies to make AstraZeneca’s vaccines to India.
Is there anything to stop the Biden administration shipping finished doses it owns overseas?
Industry executives and government officials said a clause was inserted into the original contracts signed between Donald Trump’s administration and vaccine makers, which banned the government from exporting the doses it owned. Officials said the drugmakers wanted this clause to protect them from possible lawsuits from people overseas claiming US-made doses had made them ill.
Paul Mango, the former deputy chief of staff at the health department during the Trump administration, said: “Even the president cannot export those without somehow ensuring that the pharmaceutical companies don’t become liable when they leave the country.”
Biden officials would not say how they had overcome this legal hurdle when agreeing to export 4m doses of AstraZeneca’s vaccine to Canada and Mexico, and another 60m to the rest of the world. But the answer may lie in the complex arrangement for both Canada and Mexico, where the doses are technically being “loaned” on the basis that both countries will return doses made in their own countries at a later date.
Is the Biden administration going to agree to suspend patents for vaccines?
India and South Africa have introduced a proposal at the World Trade Organization in Geneva to allow countries temporarily to override patent rights for pandemic-related medical products. The proposal has since been backed by 60 countries.
While Trump’s administration firmly opposed the waiver to intellectual property rules, along with the UK, EU and Switzerland, Biden’s top trade official Katherine Tai has rattled US pharmaceutical companies by appearing to put that position under review.
Her office has said the agency is “exploring every avenue” and “evaluating the efficacy” of the waiver, and Tai has told the WTO that she is interested in hearing more on “how the market once again has failed in meeting the health needs of developing countries”.
Proponents of a waiver to the WTO’s IP rules, known as the Trade-Related Aspects of Intellectual Property Rights, or Trips, said that temporarily suspending the rules would allow more developing countries to make their own copies of the vaccines without fear of being sued for IP infringements.
Pharma companies, however, strongly oppose such a waiver, arguing that a lack of available manufacturing capacity is causing bottlenecks, rather than IP protections.
Will this be enough?
Experts warn that even if a waiver is granted, it will take much more to make sure the rest of the world has enough vaccines. Many people are calling for makers of mRNA vaccines in particular to help set up manufacturing centres abroad, given their technology appears to be the best at tackling new variants.
“We need to establish vaccine manufacturing hubs, with technological transfer, to get the mRNA vaccine up and running elsewhere,” said Tom Frieden, the former head of the US Centers for Disease Control and Prevention. “The mRNA vaccines are much less susceptible to production delays, they’re much easier to tweak for variants, they’re probably both safer and more effective, and they’re quicker to start production. Something like that needs to be done today.”