Interim analysis of data from about 40,000 volunteers showed the biotech’s jab is only 47% effective, falling short of the study’s criteria and the minimum 50% effectiveness threshold required by US regulators.
Data for the late-stage clinical trials that were conducted in Latin America and Europe was released after the US close on Wednesday. The company, backed by the Bill & Melinda Gates Foundation, attributed its disappointing results to the fact there are at least 29 COVID-19 strains circulating in the 10 countries where its trials took place.
The Gates foundation owns about 1.7% of CureVac, or 3.1 million shares, according to Bloomberg.
CureVac’s US shares are listed on the Nasdaq and plunged after hours from $94.79 at Wednesday’s close to $49.54 at Thursday’s market open.
The 47% efficacy estimate is based on 134 COVID-cases that occurred at least two weeks after the administration of the second dose, the company said in a statement.
“While we were hoping for a stronger interim outcome, we recognize that demonstrating high efficacy in this unprecedented broad diversity of variants is challenging,” CureVac CEO Franz-Werner Haas said.
CureVac said last year that it was working with Tesla on a vaccine printer, which Elon Musk reportedly called “an important product for the world.” Musk said in a tweet about the biotech in April that it “sounds like they’re a few months away from regulatory approval.” This tweet was later deleted.
The company will continue trials of its two-dose messenger RNA vaccine and expects to publish final analysis within the next few weeks.
A COVID-19 vaccine candidate developed by the German biotech CureVac failed in a critical late-stage study, the company said Wednesday.
It’s the first failure of a major vaccine candidate in a final-stage trial. CureVac said an interim analysis showed the shot was 47% effective, falling short of the study’s goals and the minimum bar for what US regulators find approvable.
The development is a setback to the world’s immunization efforts, as European officials had previously reached deals to acquire up to 405 million doses of the shot.
Despite the disappointing result, CureVac CEO Franz-Werner Haas said the company plans to go “full speed for the final readout.” The trial is still ongoing and the final vaccine efficacy figure may vary as more COVID-19 cases are tallied.
CureVac, which is backed by The Bill & Melinda Gates Foundation, saw its stock price plummet following Wednesday’s announcement. Shares were down more than 50% in post-market trading. The foundation owns about 3.1 million shares of CureVac, or 1.7% of the company, according to data compiled by Bloomberg.
An independent biostatistics expert said it will be nearly impossible for CureVac’s study to still produce success. The 47% estimate of efficacy is based on 134 COVID-19 cases among study participants. “It’s not going to change dramatically,” Natalie Dean, a University of Florida biostatistician, told The Times.
CureVac blames variants, even as other vaccines hold up against different strains
In a statement, CureVac leaders said that the abundance of virus variants played a role in the result. Only one of the 134 analyzed cases resulted from the original strain of the SARS-CoV-2 virus, the company said.
“While we were hoping for a stronger interim outcome, we recognize that demonstrating high efficacy in this unprecedented broad diversity of variants is challenging,” CureVac CEO Franz-Werner Haas said in a statement.
The disappointing result is surprising given some of the similarities CureVac’s experimental vaccine candidate had with other, highly effective immunizations. CureVac’s shot is a messenger RNA vaccine, a new technology platform that’s also used by Moderna and Pfizer-BioNTech.
Those shots proved to be more than 90% effective in late-stage trials last year. They also appear to protect people against some major virus variants.
Other vaccines have also shown success against variants. Novavax, for instance, announced earlier this week its two-dose shot was 90% effective in a late-stage study. What’s more, Novavax’s vaccine was about 93% effective in preventing illnesses caused by variants of concern or variants of interest, the company said.
A quiet existence, until the pandemic
Since its founding in 2000, CureVac had a largely quiet existence until the pandemic. As one of the first companies trying to develop a COVID-19 vaccine, CureVac’s CEO was invited to the White House in March 2020. Shortly after, reports circulated that the US had offered a “large sum” for access to its vaccine program. CureVac disputed the reports. The company also cycled through three CEOs in the span of a week.
Tesla CEO Elon Musk has also drawn attention to CureVac with his tweets. A Tesla subsidiary is working with CureVac in building a “prototype of an automated manufacturing unit,” Insider reported in July.
In its Wednesday press release, CureVac focused attention on its second-generation coronavirus vaccine. Pharma giant GlaxoSmithKline has partnered with CureVac on that research, paying the company roughly $235 million upfront and investing an additional $180 million in multipledeals over the past year.
CureVac said it hopes this next-generation program could start human testing by the end of September, with the goal of launching in 2022.
Dr. Catherine Schuster-Bruce contributed reporting.
Bill Gates and Elon Musk don’t exactly see eye to eye.
While the Microsoft billionaire and the Tesla and SpaceX titan have never had a particularly cozy relationship, things have heated up over the past year as the two have openly sparred about everything from electric vehicles to the coronavirus.
The two moguls are among the world’s wealthiest, eclipsed only by Amazon CEO Jeff Bezos. While their public spats may not always be serious, they do appear to fundamentally disagree about the coronavirus – and as major players in virus treatment and the vaccine to protect against it, their clashes carry even more weight.
Here’s where the friction between Gates and Musk began and everything that’s happened since.
Gates doesn’t appear to be a fan of Tesla vehicles, and he’s said as much publicly.
“Elon’s positioning is to maintain a high level of outrageous comments,” Gates said. “He’s not much involved in vaccines. He makes a great electric car. And his rockets work well. So he’s allowed to say these things. I hope that he doesn’t confuse areas he’s not involved in too much.”
He noted how much energy bitcoin uses, making it not very environmentally friendly. He also warned investors not to dump money into bitcoin like Tesla has.
“Elon has tons of money and he’s very sophisticated, so I don’t worry that his Bitcoin will sort of randomly go up or down,” Gates told Bloomberg.
“I do think people get bought into these manias, who may not have as much money to spare, so I’m not bullish on Bitcoin, and my general thought would be that, if you have less money than Elon, you should probably watch out,” he said.
Musk recently tweeted, then deleted, an anti-vaccine political cartoon about Gates.
The cartoon, originally created by conservative artist Ben Garrison, depicted Gates as the mastermind of a coronavirus response plan that included making people afraid, locking the country down, and then launching a “Mandatory Vaccine Rollout.”
In Musk’s version, which wasn’t sanctioned by Garrison, the last stage of the plan is a “Zune relaunch,” in reference to Microsoft’s discontinued MP3 player.
Musk captioned the image: “Soon u will feel strange desire for Zune …” He deleted the tweet roughly two hours later.
Gates has been at the center of conspiracy theories about the coronavirus since last year, including one theory that claimed, without evidence, that Gates wanted to use COVID-19 vaccines to implant microchips into people.
UK pharma giant GlaxoSmithKline (GSK) and German biotech CureVac plan to co-develop “next generation” vaccines that could work against multiple coronavirus variants at once, the companies announced Wednesday.
The vaccines could be available in 2022, subject to authorization, and could work as a booster if immunity from another vaccine wanes, or for people who haven’t yet been immunized, the companies said.
Research suggests existing vaccines – such as those made by Pfizer and BioNTech, as well as Moderna – may be less effective against contagious coronavirus variants with certain mutations.
The companies are investing €150 million ( $180 million) in the tie-up.
The vaccines will be mRNA vaccines, which use a genetic code to trigger the body’s immune response. The COVID-19 vaccines authorized in the US, developed by Pfizer-BioNTech and Moderna, use the same technology.
Existing shots are good at protecting against the original virus, but lab-based studies suggest they may not work so well against the more contagious variants, especially against a mutation found in the variant from South Africa.
The mutation scientists believe helps the variant in South Africa escape antibodies, and could cause current vaccines to be less effective, has been detected in the variant found in the UK too.
UK pharma giant GSK already had a stake in CureVac, a German biotech specialized in mRNA technology that went public in August 2020.
“This new collaboration builds on our existing relationship with CureVac and means that together, we will combine our scientific expertise in mRNA and vaccine development to advance and accelerate the development of new COVID-19 vaccine candidates,” Dame Emma Walmsley, chief executive officer at GSK, said.
GSK will also support the manufacture of up to 100 million doses of a COVID-19 vaccine already developed by CureVac, called CVNCoV, in 2021.
CVNCoV is in late-stage clinical trials.
GSK and Curevac said they plan to develop mRNA vaccines to protect against other illnesses that cause breathing problems too.
“With the help of GSK’s proven vaccine expertise, we are equipping ourselves to tackle future health challenges with novel vaccines,” Franz-Werner Haas, chief executive at CureVac said.