Covid-19 roundup: With efficacy data in hand, BioNTech talks pricing; Brazil halts Sinovac trial following patient death
On the heels of becoming the first to release Phase III efficacy data for the Covid-19 vaccine it developed with Pfizer, BioNTech is now talking pricing.
BioNTech CSO Ryan Richardson said at a Financial Times virtual event that the company is aiming to set a price point below “typical market rate” for its two-shot vaccine, per Reuters. The firm also expects the price will be different depending on the country or region in which it’s sold, though Richardson did not elaborate.
Richardson added that whatever the price ends up being, it will reflect the financial risks incurred by the company’s private-sector investors.
“We’ve tried to pursue a balanced approach that recognizes that innovation requires capital and investment so we plan to price our vaccine well below typical market rates reflecting the situation that we’re in and with the goal to ensure broad-based access around the world,” Richardson said at the FT event, according to Reuters.
The two companies released the first look at their late-stage vaccine data Monday, saying that the candidate is more than 90% effective after an analysis of 94 confirmed Covid-19 cases. The Phase III trial has enrolled nearly 44,000 volunteers thus far, and an EUA could be on the horizon once the safety data are expected to come in later this month.
In July, Pfizer agreed to sell 100 million doses of the vaccine to the US for $1.9 billion, putting the price of a two-dose regimen at $39 per patient. And over the last several months, BioNTech has received €100 million from the EU’s financial arm and €375 million from the German government to develop the vaccine. — Max Gelman
Sinovac vaccine trial halted in Brazil after patient death
A serious adverse event has spurred Brazil’s health regulator to halt a Phase III trial of Sinovac’s coronavirus vaccine candidate — the first such setback so far for any Chinese developers.
Anvisa announced the move on its website Monday morning, surprising the Butantan Institute, the state-run biomedical research institute in São Paulo that is conducting the trial. The decision was related to the death of a volunteer in the trial, according to local media reports. Butantan head Dimas Covas said on TV that he found the decision to suspend dosing strange because the death was deemed unrelated to the vaccine.
“As there are more than 10,000 volunteers at this moment, deaths can occur … It’s a death that has no relation with the vaccine and as such it is not the moment to interrupt the trials,” Covas told local broadcaster TV Cultura, as quoted by Reuters.
In its statement, Anvisa noted that it was notified of the “event” (it didn’t specify) on Oct. 29, and now wants to evaluate the benefits and risks before deciding whether the trial should continue.
Echoing the messaging from the US and the UK when they hit the brakes on AstraZeneca and J&J’s trials, the Brazilian agency noted interruptions to guarantee safety are all part of the standard practice.
“Sinovac will continue to communicate with Brazil on this matter,” the company wrote in a statement. “The clinical study in Brazil is strictly carried out in accordance with GCP requirements and we are confident in the safety of the vaccine.”
Sinovac and Butantan had planned on testing a two-dose regimen of its inactivated virus vaccine, CoronaVac, on 13,000 volunteers in Brazil. It’s also running late-stage trials in Turkey and Indonesia.
But 3,000 of Sinovac’s own employees — including its CEO — have received the vaccine outside of clinical trials. Following an emergency use authorization based on Phase I/II data, essential workers and other high-risk groups such as students traveling overseas can also get vaccinated for about $60.
In what’s been described as vaccine diplomacy, the Chinese government has pledged that any made-in-China vaccine would be a global public good and promised priority access for countries that hosted late-stage clinical trials.
Sinovac is supposed to send 6 million doses of its vaccines to Brazil, Reuters reported. Hours before the news of the clinical hold dropped, the state of São Paulo touted the construction of a $26.5 million facility that would manufacture 100 million doses of CoronaVac per year. The site is expected to come online by next September. — Amber Tong
Amgen and Eisai join study facilitated by artificial intelligence
Two prominent drugmakers are joining a new kind of study for Covid-19 treatments that uses artificial intelligence.
Amgen and Eisai have signed on to REMAP-CAP, evaluating their experimental drugs in a global adaptive trial where an AI will rapidly compare treatments for the disease. The type of AI involved in the study, called reinforcement learning, is able to adjust treatment protocols based on how different therapies affect patient outcomes.
Running the trial will be the University of Pittsburgh Medical School. The two companies are the first in the pharma industry to join the study.
Amgen’s apremilast inhibits the activity of an enzyme found in inflammatory cells in the human body, modulating the production of inflammatory cytokines and other mediators in some Covid-19 patients. The drug is currently approved in 45 countries to treat inflammatory disease like plaque psoriasis and psoriatic arthritis.
Eisai’s Eritoran is an investigational TLR4 antagonist that had been developed for severe sepsis, where it was found to be safe in a Phase III study. The company hopes the candidate can suppress inflammation caused by Covid-19 by inhibiting the activation of TLR4. — Max Gelman
Canadian biotech Medicago says its vaccine produced a 100% antibody response in PhI
Medicago, a Canadian biotech backed by Philip Morris, has reported positive Phase I data from its Covid-19 vaccine developed from tobacco leaves.
After receiving two doses of the adjuvanted vaccine, 100% of patients registered antibody responses, the company said in a press release Tuesday. In a preprint of the study, also published Tuesday, the vaccine reportedly did not cause any severe side effects.
The trial itself evaluated three dosage levels in the 180 patients. Medicago studied drug arms of 3.75 μg, 7.5 μg and 15 μg using either its virus-like particle-based vaccine alone or with one of two adjuvants from GSK and Dynavax. Even at the lowest adjuvanted dose, neutralizing antibody titers were 10 times higher than those found in the blood of patients who recovered from Covid-19 on their own.
Additionally, all patients in the group with GSK’s adjuvant developed anti-spike IgG antibodies after a single dose of the vaccine, at all dosage levels. Medicago also says its vaccine candidate can be stored at temperatures above freezing — between 2 and 8 degrees Celsius.
With the results, Medicago plans to move into a Phase II/III trial sometime soon, though they didn’t specify exactly when. The company said that the data supports taking the lowest dose into further trials, but it wasn’t immediately clear that’s what it plans to do.
Medicago has previously said it could make up to 100 million doses of its vaccine candidate in 2021. The biotech ranks 9th in Endpoints News’ Covid-19 vaccine race tracker. — Max Gelman
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