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The competition among governments to secure access to medicines and future vaccines against coronavirus has been fierce, fanning fears of a zero-sum game between countries battling the pandemic. But it hasn’t turned drug regulators from around the world against each other.
On the contrary, it has brought them closer together, says Guido Rasi, the boss of the European Medicines Agency (EMA), which is in charge of recommending drugs and vaccines approvals for all 27 members of the European Union.
As Rasi tells POLITICO, a unified front among global regulators on the data necessary to approve new medicines or vaccines for the novel coronavirus will help them withstand political pressure at home.
“If everybody else has this position, it’s easier for one to stand and to explain that it’s not [only the individual agency's position], it’s a global view,” he said. “In that perspective it’s giving a lot of strength to each one of us.”
An Italian doctor who has been at the helm of the EMA for almost a decade, Rasi also chairs the International Coalition of Medicines Regulatory Authorities, a voluntary cooperation between some 28 drug agencies around the world, including the U.S. Food and Drug Administration, China’s National Medical Products Administration and Brazil’s National Health Surveillance Agency.
The coalition existed long before the pandemic, but the cooperation has become more intense, with virtual meetings every two weeks meant to help expedite and streamline the development, approval and availability of Covid-19 treatments and vaccines worldwide.
The EMA and the FDA take turns in chairing the meetings, Rasi said.
Japan’s drug regulator is also very involved, and the Nigerian one has become very active in the talks recently, he said.
FDA officials weren’t available to speak to POLITICO about the cooperation, but an article posted on the agency’s website at the end of June touts the cooperation with the European Union, Japan and Canada on coronavirus therapies.
“We will continue to collaborate with our global regulatory counterparts as we seek to bring safe and effective Covid-19 vaccines and treatments to our citizens as quickly as possible,” states the article, signed by the FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs Anna Abram and Mark Abdoo, Associate Commissioner for Global Policy and Strategy.
China’s National Medical Products Administration could not be reached for comment about the cooperation.
A media spectacle of concern
The talks between drug agencies are about how to manage the smaller than usual amount of data they have at their disposal as they decide whether to approve a Covid-19 drug and, in the future, a vaccine.
The regulators are concerned about the small studies drugmakers and biotech companies are using to test vaccines, according to Rasi.
“This fragmentation is going to produce a lot of underpowered studies with inconclusive data — with a good signal, but inconclusive,” he said.
The drip-drip of information appearing in the media about the good results coming out for different medicines or vaccines under development amounts to a public relations competition that developers are playing among themselves, Rasi said.
The latest example came earlier this week.
An experimental vaccine developed by U.S.-based Moderna triggered an immune response without major side effects in an early-stage clinical trial, scientists reported Tuesday.
A day later, a U.K. news outlet reported that a vaccine in the works by Oxford University and pharma company AstraZeneca also generates an immune response against the disease.
But for drug regulators in ICMRA, “all the vaccines are on the same level of development, because we have no single data on the table,” Rasi said.
Regulators will still need to get their questions answered when vaccine developers request approval, he said. “On that there will be no discount.”
Political currents
The U.S. and European governments have been competing for access to drugs against coronavirus. When news emerged at the end of June that the U.S. had bought virtually all the stock of such a drug, remdesivir, for a couple of months, the EU was quick to say they were also in talks with drugmaker Gilead to secure access.
But this kind of competition hasn’t affected the cooperation between the European and American drug regulators, Rasi said.
“The competition is a little bit at another level. It’s more for the negotiators, the government,” he said.
But that doesn’t mean regulators don’t diverge on what they do at home.
The FDA, for example, gave an emergency approval in the spring to hydroxychloroquine, a drug touted by U.S. President Donald Trump to work against the virus. It then revoked it in June, when results from clinical trials showed not only that it wasn’t effective, but that it may even have potentially dangerous side effects for those who take it.
“The level we discuss is the scientific level and we agree,” Rasi said. “Then each one in each jurisdiction may have to take a little bit of a different approach.”
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