Covid-19 roundup: Pfizer, BioNTech forge ahead with enhanced vaccine; Brii moves on antibody to counter subvariants
While Pfizer and BioNTech’s Covid-19 vaccine has been one of the primary treatments so far in the pandemic, both companies are still adjusting and making improvements amidst the spread of the Omicron variant and its subvariants.
And now the latest step has come through. Both companies announced Wednesday that they have kicked off a Phase II study to evaluate an enhanced version of the vaccine candidate at a 30 µg dose level.
This vaccine candidate, called BNT162b5, consists of enhanced prefusion spike proteins for the ancestral strain and an Omicron variant. According to Pfizer and BioNTech, the enhanced spike protein has been modified to increase immune response that could better protect against Covid-19.
This experimental shot is the first of multiple potential candidates as part of a long-term vaccine strategy to generate longer-lasting vaccines with broader immune responses.
The vaccine will also be evaluated in the US, enrolling around 200 participants aged between 18 and 55 who have received one booster dose of the current vaccine at least 90 days before their first study visit. The study also does not include a placebo.
Wednesday’s move comes as the FDA’s adcomm has been looking into data from Pfizer and BioNTech to update the vaccine and offer better protection against Omicron as fall and winter loom.
Brii Biosciences presents data for its antibody cocktail against Omicron’s subvariants
Last year, Brii Biosciences’ Covid treatment, and a few others, were shown the door by the NIH after its antibody therapy failed to show a trend toward clinical benefit. However, Brii is not giving up and is presenting new data.
On Tuesday, the company announced it had new live virus data confirming that its cocktail, containing a combination of amubarvimab and romlusevimab, retains neutralizing activity against the Omicron BA.4 and BA.5, as well as the BA.2.12.1 subvariants.
According to Brii, the data predicted that total serum concentrations from the treatment will remain more than 170 times the level required for greater than 90% neutralization against the live virus, 14 days after dosing.
Brii also stated that the FDA is currently reviewing the treatment for an EUA application.
“We’re at a critical moment in the pandemic in which the new Omicron subvariants are more contagious, resulting in a sustained urgency for safe and effective treatment options. We look forward to continuing our discussions with global regulatory bodies as we work to advance this innovative combination therapy for COVID-19 patients in need around the world,” said David Margolis, VP at Brii Bio, in a statement.
After flopping with HHS in 2021, the company found some success in a second trial later that year, with the new cocktail improving patients’ odds of being hospitalized or dying over placebo, notching a statistically significant reduction of 78%.