A new dawn?

The most advanced of the experimental coronavirus vaccines are providing glimmers of hope for advancing the battle against COVID-19, having reported late-stage data with higher than expected levels of protection.

A final efficacy analysis of Pfizer and BioNTech’s mRNA vaccine BNT162b2 showed that it is 95% effective at preventing COVID-19, in participants with and without prior SARS-CoV-2 infection.

The analysis is based on 170 cases of COVID-19, of which 162 cases were observed in the placebo group versus eight cases in the BNT162b2 arm. Crucially, indications are that efficacy is consistent across age, gender, race and ethnicity demographics, with the observed efficacy in adults over 65 years of age over 94%.

The study’s findings “highlight the potential of mRNA as a new drug class”, said Ugur Sahin, chief executive and co-founder of BioNTech. “Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages. We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far.”

The companies also highlighted that the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine, adding that data from a randomised subset of at least 8,000 participants has shown the vaccine to be well tolerated, with most solicited adverse events resolving shortly after vaccination.
  
In further good news for the fight against the virus, Moderna’s vaccine mRNA-1273 showed efficacy of 94.5% in the Phase III Cove trial, with the primary analysis based on 95 cases of COVID-19, 90 of which were recorded in the placebo group versus five cases in the mRNA-1273 arm.

As with BNT162b2, Moderna’s vaccine was found to have a safety and efficacy profile consistent across all evaluated age groups, while a review of adverse events indicated that the vaccine was generally well tolerated, with the majority of side effects mild or moderate in severity, it said.

“This positive interim analysis from our Phase III study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” noted Stéphane Bancel, the company’s chief executive.

AstraZeneca and Oxford University’s coronavirus vaccine ChAdOx1 nCoV-19 also seems to be faring well, scoring an average efficacy rate of 70% in an interim analysis of Phase II/III trials conducted in the UK and Brazil, with one dosing regimen showing efficacy as high as 90%. Also, early Phase II data indicate that it induces a strong immune response in older adults in their 60s and 70s, thus potentially offering protection to age groups at higher risk from the disease.

The UK government has on order 100 million doses of the vaccine, as well as 40 million doses of the Pfizer/BioNTech’s and five million of Moderna’s, with priority groups set to be the first to receive those winning regulatory approval, potentially early next year.

Also of note, a Phase III trial of the Sputnik V vaccine – developed by Russia’s Gamaleya Center and the first in the world to become registered with a regulatory authority after it was approved by Russia’s Health Ministry – showed efficacy levels of around 92%.