It’s not too late for the United States to become the world’s vaccine superpower, producing and exporting enough doses to protect entire countries against COVID-19.
Under pressure to help countries such as India that are suffering devastating surges in infections and deaths, the Biden administration has begun to cut through some of the bureaucratic red tape standing in the way. But experts say the White House should be ruthless when it comes to zeroing out rules and regulations that prevent U.S. firms—and the government itself—from shipping more doses overseas.
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“I think the U.S. has to do the equivalent of a World War II ‘arsenal of democracy’ or a Marshall Plan,” Lawrence Gostin, a Georgetown University global health expert, told The Daily Beast. He was referring to the federal government’s plans—during and after the last global war—to supply and rebuild allies and former foes.
The United States alone possesses the wealth, industrial base, supply chain, and intellectual resources to become a major vaccine exporter. America is also alone among big countries in having quickly vaccinated a majority of adults with proven and highly effective vaccines, meaning it can responsibly begin sending doses abroad without depriving its own.
China and Russia also produce a lot of vaccines and have access to global supply chains. But both of those countries are pushing locally developed vaccines that haven’t been as thoroughly tested, and may not offer the same level of protection.
The U.S. Food and Drug Administration has granted three U.S.-based companies emergency authorization to distribute vaccines in the United States. New York-based Pfizer and Moderna in Massachusetts produce two-dose vaccines based on the latest messenger-RNA technology. New Jersey-based Johnson & Johnson makes a traditional single-dose vaccine.
All three of the vaccines have been thoroughly tested and offer more than 90 percent protection against the SARS-CoV-2 virus. They’re even more effective—close to 100 percent—at preventing serious illness, hospitalization, and death.
The feds have spent billions of dollars buying hundreds of millions of doses of the three vaccines—plus tens of millions of doses of a vaccine from U.K. pharma AstraZeneca that, while in circulation in much of the world, hasn’t gotten the FDA nod yet.
Since December, the U.S. government has received 330 million doses from the pharmaceutical industry. After months of intensive effort by hospitals and pharmacies and national, state and local officials, over 263 million doses have been administered in the USA.
Over 153 million Americans have gotten at least one dose. Over 116 million have been fully vaccinated. The rapid inoculation of the U.S. population is the main reason the COVID infections, hospitalizations, and deaths are falling despite the spread of new and more transmissible variants of the pathogen. And, it should be noted, all this despite vaccine hesitancy and outright hostility limiting their reach domestically.
America’s vaccination campaign has been among the most successful in the world, but vaccine uptake has been slowing lately as the most eager takers finish getting their shots. That, and the government’s jealous hoarding of locally-made doses, has resulted in a surplus. The U.S. is sitting on around 70 million doses of vaccine, including millions of AstraZeneca jabs.
While the USA practically swims in vaccines, most of the rest of the world is short. On average, just 3 percent of the world’s population has been vaccinated. And millions got Russian or Chinese jabs that didn’t undergo rigorous large-scale trials.
America’s high vaccination rate and surplus of doses compared to most of the world underscores the global vaccine equity problem.
Richer countries with a strong local pharmaceutical industry and solid scientific credentials have lots of effective vaccines. Poorer countries—or those lacking high-quality pharma firms—are still mostly unprotected against the virus. It could be a year or more before less developed countries can vaccinate a majority of their citizens.
It can’t be overstated that the lack of protection is a problem for the whole world. Every unvaccinated population is a laboratory for the novel coronavirus. Surges in cases anywhere can produce new variants. Those variants can then spread. If a new variant is more transmissible or proves resistant to vaccines, it poses a serious threat even to countries that are highly vaccinated.
The United States could speed up the global vaccination timeline, save potentially tens of thousands of lives, and head off possible dangerous new variants. All it takes is for the country to turn its internal vaccination campaign outward. The U.S. government, working closely with domestic industry, could deliver millions of doses all over the world.
This is already happening, but only to some extent. The Biden administration has pledged to export all 60 million AstraZeneca doses it’s already paid for—starting with millions for virus-ravaged India. At the same time, Biden has donated $4 billion to an international vaccination campaign called COVAX. His administration also turned heads recently when it backed an initiative at the World Trade Organization to suspend patent protections for COVID vaccines, in theory allowing any firm anywhere to produce doses—and sticking it to Big Pharma along the way.
But there’s a lot more the White House could do, experts said, and now. “First thing we could do is cease the export restrictions that are in place,” Amesh Adalja, a public health expert at the Johns Hopkins Center for Health Security, told The Daily Beast.
Those restrictions are extensive. When the Trump administration wrote the initial contracts for vaccines from the big pharmas including Moderna, Pfizer, and Johnson & Johnson, it included clauses largely barring the companies’ U.S. factories from shipping doses abroad until after they filled all domestic orders. In exchange, the Trump administration pledged billions of dollars to the firms’ research and development and production ramp-up.
To give the contracts even stronger legal backing, Trump invoked the 71-year-old Defense Production Act, which gives presidents broad authority to restrict domestic industry.
Biden has largely continued Trump’s vaccine-production policies. The White House’s plan to offload its unusable (in the U.S.) AstraZeneca jabs is an exception to the rule. To vaccinate the world, the Biden administration should lift export restrictions, Adalja said. “I mean all of the export restrictions—not piecemeal, which is what they’re doing,” he added.
Kevin Munoz, a White House spokesperson, defended the restriction. “Those are for U.S. companies only and for U.S. companies receiving [U.S. government] support,” Munoz said. “Most companies—if not nearly all, including vaccine manufacturers—are exporting and have been for some time.”
But the U.S. companies receiving federal support are some of the biggest pharmas in the world—and the biggest producers of COVID vaccines. Freeing them up to ship more jabs abroad could spread vaccines more equitably across the planet.
After ending restrictions, the U.S. government could finance doses for poorer countries, much in the way the government already finances American-made weaponry for some of its more cash-strapped allies. A billion dollars is a rounding error in the federal government’s $4.5-trillion annual budget, but it could buy 50 million doses of an mRNA vaccine. That’s enough to vaccinate the entire population of Cameroon or Niger.
There’s a catch, and it’s one familiar to Americans who have followed the vaccine rollout closely. The mRNA vaccines require cold storage, which makes them difficult to ship and store. “Most underdeveloped countries would not benefit from these fragile products,” Henry Wang, a chemical engineering professor who studies vaccine production at the University of Michigan, told The Daily Beast.
If the feds are going to produce vaccines for the world, they should prioritize the conventional jabs from AstraZeneca and Johnson & Johnson, neither of which requires deep freezing. The problem there is that both vaccines have a bad reputation—undeservedly, according to many experts.
Regulators all over the world have authorized the AstraZeneca vaccine for distribution, but the FDA hasn’t. U.S. regulators balked after reports of minor flaws in AstraZeneca’s trials data, and reports of very rare blood-clotting. Likewise, the FDA briefly suspended distribution of the Johnson & Johnson jab in the United States last month after a handful of recipients of the vaccine—initially just six individuals out of seven million—suffered blood clots.
The FDA’s extreme caution is, in part, a product of privilege. Americans don’t need the AstraZeneca and Johnson & Johnson jabs. The country is already sitting on a surplus of Moderna and Pfizer vaccines.
But other countries are desperate. And American regulators have done them a disservice by casting a negative pall over the only vaccines that some countries with limited cold-chain logistics can handle. “The bad publicity may... affect their uptake in other countries,” Wang said of the AstraZeneca and Johnson & Johnson shots.
To repair the damage, the FDA could strongly endorse the Johnson & Johnson vaccine and finally grant AstraZeneca authorization for domestic use, one Americans don’t need but which could reassure the rest of the world. The FDA did not respond to a request for comment.
Once it has cut the red tape, allocated funding, and bolstered the reputations of the easiest-to-handle vaccines, the U.S. government could begin to finesse infrastructure for an American-led global vaccination campaign. The least-developed countries might need finished doses and a lot of help storing and administering them.
“We need someone to produce 5 billion doses of our vaccine for Africa,” Peter Hotez, a professor of pediatrics and molecular virology & microbiology and dean of the National School of Tropical Medicine at Baylor College of Medicine, previously told The Daily Beast. “If you wanted to make billions of doses of mRNA vaccine for Africa, what you need is Moderna and Pfizer to send a team of scientists and create a manufacturing plant.”
Moderna and Pfizer did not respond to requests for comment for this story.
But more developed countries that nevertheless are struggling to vaccinate their citizens might actually have a domestic pharma industry that could, with some financial and technical assistance, manufacture doses. That would relieve the United States of the burden and cost of shipping doses. America could send money and technicians, instead.
Taken together, these steps could free up America’s growing pile of excess doses and mobilize U.S. money, power, and prestige to speed up vaccination all over the world. It might cost U.S. taxpayers a few billion dollars. But it could save lives here and abroad and, in the end, benefit everyone.
“We need to think big and bold, with lavish funding, close partnerships and technical assistance, and supporting regional vaccine manufacturing hubs,” Gostin said. “That is our only way out of the pandemic.”
