Covid-19 roundup: Pfizer licenses its pill to the Medicines Patent Pool; NYC joins states in authorizing boosters for all adults ahead of FDA
Following a similar deal forged by Merck for its Covid-19 drug molnupiravir, Pfizer on Tuesday agreed to allow the UN-backed Medicines Patent Pool to license the company’s potential treatment Paxlovid to make it more readily available in 95 low- and middle-income countries.
The agreement allows MPP to grant sub-licenses to qualified generic drug manufacturers to facilitate additional production and distribution of the investigational antiviral, which has yet to be authorized.
Pfizer has not disclosed a price for its treatment but executives have said they will price it similarly to Merck’s molnupiravir, which costs about $700 per treatment course in high-income countries.
While the move to license its drug, even before its authorization, may be viewed as a noble effort, Doctors Without Borders said in a statement, “Licensing deals by pharmaceutical corporations that create uncertainties and segmentation for generic production and supply continue to be part of the problem rather than part of a real solution. There is no patent yet on the experimental candidate PF-07321332, and ritonavir has been off patent since last year. In the absence of patents on both compounds, able manufacturers, particularly those based in countries excluded from this license, have an opportunity to explore generic production directly.”
NYC joins states in authorizing Covid-19 boosters for all adults ahead of FDA authorization
New York City is joining California, Colorado, Arkansas, and New Mexico in allowing any adult to access a Covid-19 booster shot. Some, like cardiologist Eric Topol, called the decision “fully backed by the data,” as Pfizer and BioNTech maintain that the waning immunity from the initial 2-dose series needs the boost to get back into the 90%+ range for protection.
Others seem concerned that such a decision isn’t necessarily backed by robust data, or that such doses should be shipped abroad as initial doses. Others still question the need for states to override the FDA’s decision to only authorize the boosters so far for certain groups of people, including those older than 65.
The FDA, however, wasn’t keen to discuss the issue. An agency spokesperson told Endpoints News to contact the CDC for assistance with any questions, adding, “It is important to note that FDA does not make immunization or clinical recommendations.”
On whether states should be authorizing boosters ahead of an FDA decision for the same age group, or if this was more an issue of off-label use (because Pfizer’s vaccine is FDA approved), the agency spokesperson said, “We do not have anything additional to add to our previous response.”
BREAKING: NYC Health Dept authorizes covid booster shots for *all* NYers aged 18+, as long as at least 6 months since 2nd Pfizer/Moderna dose or 2 months since J&J dose.
This is a welcome move at a time when cases are rising in NYC.
Make an appt here: https://t.co/h2ivjxUFu2
— Mark D. Levine (@MarkLevineNYC) November 15, 2021
Twist Bioscience reveals an antibody offshoot with a start in Covid-19
Twist Bioscience unveiled an offshoot biotech this morning — Revelar Biotherapeutics, which is working on a potential Covid-19 antibody.
According to Twist, the independent new biotech will be developing and commercializing an antibody that has neutralized all known variants of SARS-Cov-2 in preclinical trials.
That said, Revelar can leverage Twist’s antibody platform and license additional antibodies — up to five more targets over the next four years, each of which will be subject to additional upfront, milestone and royalty payments to Twist.
Twist CEO Emily Leproust said in a statement that she hopes the antibody will enter clinical studies in 2022.
Twist is starting out with a $10 million seed investment, based on Revelar’s development of the first antibody and the potential for success-based milestone payments totaling over $100 million. In exchange for the investment and antibody licensing, Twist got minority ownership in Revelar — but at an unspecified percentage.
Revelar’s executive leadership team includes Boehringer vet Glenn Marina as CEO. Leproust and Twist CCO Patrick Finn are also part of the board of directors.
“We look forward to completing preclinical and CMC development in support of filing an IND,” said Marina in a statement. — Paul Schloesser
EU and EEA countries agreed to donate 70+ million doses of Moderna vax to low- and middle-income countries by year’s end
Moderna today announced an agreement that enables the EU and EEA countries to donate doses of their Covid-19 vaccine purchased under the EU Vaccines Strategy to COVAX for low and middle-income countries for the rest of the year.
The vaccine doses will be headed to 92 countries considered as low- and middle-income.
According to a Moderna statement, the company expects to see more than 70 million doses given away by year’s end as part of the initiative spearheaded by France, Sweden and Norway. Initial donations have included 15 million from France and 40 million from Germany.
“We believe that dose sharing, among other strategies, will help ensure an equitable global distribution of COVID-19 vaccines,” said Moderna’s CEO Stéphane Bancel, who has come under fire recently from the Biden administration for not helping enough on the international stage. — Paul Schloesser