Covid-19 roundup: CureVac pushes ahead for vaccine authorization despite failing to hit 50% efficacy threshold
All mRNA vaccines are not created equal. And Germany-based CureVac found out the hard way on Wednesday as its pivotal trial showed its vaccine is 48% effective against Covid-19 across all age groups studied.
While regulators have set the efficacy bar at 50% for new Covid-19 vaccines, CureVac CEO Franz-Werner Haas made clear on Wednesday that he still intends to still seek licensure for the vaccine, particularly in the EU and for certain age groups that performed better in the trial than the overall result.
“In this final analysis, CVnCoV demonstrates a strong public health value in fully protecting study participants in the age group of 18 to 60 against hospitalization or death and 77% against moderate and severe disease – an efficacy profile, which we believe will be an important contribution to help manage the COVID-19 pandemic and the dynamic variant spread,” he said in a statement.
Haas also told the Washington Post in an interview that CureVac is in discussion with the European Medicines Agency about the data, with an emphasis on that 18 to 60 year old group. The European Commission last November ordered 225 million doses of the vaccine, with an option to buy 180 million more.
But a member of the German parliament tweeted on early Thursday that he did not think the vaccine would be authorized, even for the limited population, although he still thinks the German government was right to invest in CureVac.
Curevac wird auch keine Zulassung für die 18-60 Jährigen bekommen. Dafür ist Wirksamkeit von 53% in der Gruppe zu gering. Es ist schade, aber so geht Wissenschaft. Das Konzept war clever und ging nicht auf. Trotzdem war es richtig, dass Bund investiert hat https://t.co/kpRnJo9255
— Karl Lauterbach (@Karl_Lauterbach) July 1, 2021
Breakdown of trial results: Of the 228 cases of Covid-19 that occurred during the Phase IIb/III trial in about 40,000 healthy participants, 83 were among those receiving the experimental vaccine, while 145 cases were among those administered placebo.
And while the vaccine proved to be 100% protective (0 cases among those receiving the vaccine vs. 6 on placebo) against hospitalizations or death, CureVac also said that in participants above 60 years, “the available data did not enable a statistically significant determination of efficacy.”
What’s next: As CureVac awaits word from the EMA, the company is also working on second-generation Covid vaccine candidates in partnership with GSK, and expects that the first candidate will reach clinical testing in the third quarter of 2021, with the goal of marketing the vaccine next year.
Disagreements among WTO members persist on waiver to roll back IP protections for Covid vaccines
As the European Union hardens its opposition to temporarily waiving IP protections, splits among the factions supporting such a waiver are beginning to show, according to Law360 coverage of an informal meeting convened in Geneva by Ambassador Dagfinn Sørli of Norway.
While any waiver will require the unanimous agreement of the WTO’s 159 members (and more than 100 members support such an IP waiver), discussions among those in favor of the waiver are splintering over whether to include more than just vaccines. The Biden administration has pledged its support for just a vaccine waiver, seeking a more pragmatic approach, while the South Africa delegation is seeking to extend the waiver to “priority medical devices,” such as ventilators, patient monitors and medical and surgical masks, as well as the raw materials needed to make the vaccines.
The EU maintains that its alternative plan, which wouldn’t actually waive any IP, could do more to build up vaccine supplies. And in the informal negotiations on Wednesday, the US joined with the EU — along with the UK, Switzerland, Mexico, Japan and Brazil, among others — in arguing that greater access to Covid vaccines and therapeutics would still be possible while largely maintaining IP laws as they are.
EU launches digital certificate to ease travel for those who’ve been vaccinated
The European Commission on Thursday officially launched its “EU Digital COVID Certificate Regulation,” to ease the process of traveling between EU countries for those who are vaccinated.
Under the new rules, EU member states are not allowed to impose additional travel restrictions on holders of a certificate, unless they are necessary and proportionate to safeguard public health.
“In March, we promised to have an EU-wide system to facilitate free and safe travel within the EU by the summer holidays. Now we can confirm that the EU Digital COVID Certificate system is up and running,” said EC president Ursula von der Leyen. “A vast majority of EU Member States are already connected to the system and ready to issue and verify the Certificates. More than 200 million certificates have already been generated.”