A White House spokesperson on Tuesday said that the United States would not be joining the COVAX Facility, an initiative led by the World Health Organization and its partners to pool global demand for a COVID-19 vaccine, and ensure its equitable distribution.

“The United States will continue to engage our international partners to ensure we defeat this virus, but we will not be constrained by multilateral organizations influenced by the corrupt World Health Organization and China,” White House spokesman Judd Deere said in a statement.

“This President will spare no expense to ensure that any new vaccine maintains our own FDA’s gold standard for safety and efficacy, is thoroughly tested, and saves lives,” Deere added. 

The US’ refusal is a blow to the COVAX Facility – led by the WHO, Oslo-based Coalition for Epidemic Preparedness Innovations (CEPI), and Gavi, the Vaccine Alliance – which is still in the process of negotiating final commitments from countries. 

If successful, the COVAX Facility could set a historic precedent and overturn a tide of “vaccine nationalism” in which rich countries have placed pre-orders for promising investigational vaccines, potentially leaving poorer countries in the dust. 

The COVAX Facility is designed to have rich countries help subsidize the cost of a vaccine for lower-income countries, and may be the best chance for poorer countries to get their hands on an effective COVID-19 vaccine as soon as possible. So far, over 170 countries, including 92 low and middle-income countries that qualify for development aid have expressed interest. The European Commission and Germany both made public commitments to join the initiative on Monday.

But since the Trump administration indicated its intent to withdraw the US from the WHO to Congress and the United Nations in July, it has distanced itself from most global COVID-19 initiatives, particularly those involving the WHO. While initially Trump praised the WHO response to the pandemic, the president began criticizing the agency for allegedly failing to act in a timely fashion and catering to China in March, shortly after the epidemic began accelerating in the US. 

United States Leans On Operation Warp Speed

Now, as the US surpasses 6 million confirmed COVID-19 cases, the Trump administration is hedging its bets on Operation Warp Speed, a government initiative to roll out an effective COVID-19 vaccine to the masses by January 2021. Under Operation Warp Speed, Moderna, AstraZeneca, and Johnson&Johnson have received massive infusions from the US Department of Health and Human Services to finance vaccine development. 

US Food and Drug Administration Commissioner Stephen Hahn even told the Financial Times on Sunday that the FDA may consider approving a vaccine for emergency use before final phase trials are concluded, if preliminary data shows that the benefits outweigh the risks. This strategy would follow closely in the footsteps of Russia, which drew both criticism and offers to collaborate when it announced it had approved a COVID-19 vaccine in early August, ahead of final phase clinical trials.

However, the World Health Organization warned against premature approval of a vaccine candidate on Monday.

“The risk of approving a vaccine prematurely for us is that first of all, it will make it very difficult to continue with randomized clinical trials,” said WHO Chief Scientist Soumya Swaminathan.
“And secondly, that there’s a risk of introducing a vaccine that’s been inadequately studied. And that might either turn out to have low efficacy, thereby not doing the job of bringing an end to this pandemic. Or even worse, it could have a [poor] safety profile, which is just not acceptable.”

“The move to use a drug or a vaccine from an emergency point of view does not take away the need to collect important information,” added WHO Executive Director for Health Emergencies Mike Ryan. “The difficulty right now is we’re moving from vaccinating tens or hundreds of people to thousands [in Phase III trials]…and certain adverse events you won’t pick up with smaller numbers. You need to maintain monitoring.”

But ultimately, said Ryan, each country has a sovereign right to define its own vaccine policy. 

The Trump administration has already  inked bilateral deals with a number of vaccine developers, including Moderna and Johnson&Johnson, to produce millions of doses of their COVID-19 vaccine candidates. Manufacturing for these doses will begin as final phase clinical trials are still being conducted for these vaccine candidates, so that doses will be ready to ship if the investigational vaccines prove safe and effective.

Image Credits: Flickr: Radek Kucharski.