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Is this how the CureVac vaccine ends — not with a bang but with wimpy efficacy results?
The German-made mRNA vaccine was once so sought-after that former U.S. President Donald Trump allegedly wanted to poach the company before it was rescued by Commission President Ursula von der Leyen. She praised the vaccine as the “frontrunner” in the spring of last year, with the Commission offering the firm an €80 million loan.
But now, the CureVac vaccine is just an mRNA vaccine late to the game and coming up short after preliminary data showed it was only 47 percent effective in preventing COVID-19 cases.
The news, issued late Wednesday night, was a shock to the EU’s vaccination strategy. The bloc might be rolling in doses now, especially those from BioNTech/Pfizer, but it’s still eager to have the CureVac jab for booster shots. Indeed, the EU already secured 405 million doses, and the German shot would be the latest in the mRNA family.
But the poor efficacy results put the vaccine far below its mRNA siblings as well as the adenovirus shots approved by EU regulators. It also lags behind China’s Sinovac vaccine, which is posting only slightly above 50 percent efficacy in some studies.
The key players haven’t given up hope — yet. Commission spokespeople are declining to say whether the EU will toss out its contract for hundreds of millions of doses with CureVac based on the preliminary data. For its part, the contract says it can be terminated if the vaccine proves not to be safe or effective in clinical trials or fails to get approval from regulators.
Regardless, Commission spokesperson Stefan De Keersmaecker emphasized that the EU already has a “diversified portfolio” that will allow 70 percent of adults in the EU to be immunized by the end of the next month with its current producers, which is also in line with POLITICO’s estimates.
Similarly, the European Medicines Agency has declined to say the vaccine’s future is over yet. The agency last year asked vaccine producers to prove their shots are at least 50 percent effective at preventing COVID-19 cases, but regulators said Thursday that it would also look at the vaccine’s complete portfolio of data when deciding whether to recommend it for approval.
“Only then it will be possible to understand whether what has been proven in terms of efficacy and safety could be sufficient for a market authorization,” explained Marco Cavaleri, the head of vaccine strategy at the EMA.
Some experts say the vaccine could still be worth a shot.
“I would be wary of being too dismissive of this vaccine based on the very limited information provided to date,” Peter English, a retired consultant in communicable disease control and the immediate past chair of the U.K.’s BMA public health medicine committee, wrote in a statement to press.
For one, the efficacy rate is based on preventing COVID-19 ranging from mild to severe — but many vaccines, including coronavirus vaccines, are better at preventing severe cases and are judged accordingly, he noted.
“It’s likely that the efficacy of [CureVac’s] vaccine against severe illness — hospital admission, critical care needs (ICU admission), and death will be higher, possibly considerably higher than the efficacy against ‘disease of any severity,'” he wrote.
There’s also evidence that the vaccine is more effective in younger people, according to CureVac.
These results aren’t the final word in any case. It’s possible that the vaccine’s efficacy could increase upon final analysis as scientists analyze more coronavirus cases in its late-stage trial, which covers 40,000 volunteers at 10 sites in Europe and South America.
Still, the future of CureVac’s vaccine looks bleak. And if more data confirms it can’t compete with the variants that have become dominant in many countries, the vaccine’s future could be over.
Scientists sequenced 474 coronavirus cases in the trial and found that, out of 124 cases that could be determined so far, only one was the original coronavirus strain. In a presentation to shareholders Thursday, the company reported that 41 percent of those cases were attributed to the Alpha variant, first identified in the U.K.
“Our technology had to prevail in one of the most challenging COVID-19 environments,” said CureVac CEO Franz-Werner Haas, adding that the company had been “hoping for a stronger outcome.”
To be sure, all vaccines are at risk of becoming less effective due to variants. A majority of epidemiologists surveyed in March warned that variants could render the world’s vaccines ineffective within a year.
The EMA’s Cavaleri was less alarmist on Thursday, calling it “premature” to know exactly how variants are impacting vaccine performance. But he noted the jabs approved and in use in Europe seem to be “holding quite well against the majority of the virus that are circulating right now.”
Indeed, Public Health England data showed the BioNTech/Pfizer vaccine was 92 percent effective against the Alpha variant and 79 percent effective against the Delta variant, first identified in India, while Oxford/AstraZeneca’s vaccine was 73 percent and 60 percent, respectively. Real world data has shown that vaccines are at the very least decreasing hospitalizations.
English, however, notes the Beta variant, first identified in South Africa, and the Delta variant have been the two denting vaccine efficacy the most so far. But the Delta variant accounted for only about 2 percent of the sequenced cases in the CureVac trial, while CureVac didn’t mention any cases from the Beta variant.
“As the Delta variant — which appears to be considerably more transmissible — becomes more prevalent, it will be important to know if this vaccine is effective at preventing this variant,” he wrote.
So far, CureVac’s shot looks uniquely poor against variants in general. The company’s representatives said Thursday that they would wait for the final analysis before deciding next steps, expected in the next two to three weeks.
“There is no reason to slow down anything,” said Haas. “For now we are going full speed exactly where we are.”
Still, Haas emphasized that this first-generation vaccine isn’t the only coronavirus vaccine in its toolbox.
The biotech company has also teamed up with GSK to produce a second generation vaccine that targets variants with a “new messenger RNA backbone.” Currently the two companies are testing the vaccine in labs and report a strong immune response. This candidate will move to human studies next quarter.
In a separate project, CureVac has partnered with the U.K. government to research the future of coronavirus vaccines. The British government secured a supply of 50 million doses of any vaccine that comes out of this project.
This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email [email protected] for a complimentary trial.
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