Covid-19 roundup: EMA recommends Moderna vaccine for authorization; Woodcock returns to FDA as Hahn advisor — reports
After delaying its decision earlier this week, the EMA announced it has formally recommended authorizing Moderna’s Covid-19 vaccine.
Regulators came to the decision Wednesday morning, marking the second vaccine given authorization in Europe following Pfizer and BioNTech. EMA had previously scheduled a deadline for Jan. 12 to reach a decision.
The ball will now head to the European Commission’s court, which has the final say on any opinions given by the EMA and CHMP. Should the body give it the thumbs up — a virtual certainty — the EU would become the fourth to OK the vaccine, following authorizations in the US, Canada and Israel.
Wednesday’s decision comes about one week after Moderna locked down a deal with Swedish CDMO Recipharm for work on an undisclosed portion of Moderna’s vaccine supply outside of the US.
Back in December, the European Commission exercised an option to purchase 80 million additional doses of Moderna’s shot, bringing its commitment to 160 million doses. — Max Gelman
Woodcock back at FDA as Hahn advisor
Former CDER director Janet Woodcock is reportedly back at the FDA after stepping aside to join Operation Warp Speed.
Woodcock has joined the agency as principal medical advisor to FDA commissioner Stephen Hahn, according to an internal email obtained by Politico. She will still retain her role with OWS and remain recused from decision-making surrounding Covid-19 therapeutics.
Additionally, Woodcock is expected to work on the agency’s Covid-19 Pandemic Recovery Preparedness Plan (PREPP) initiative with Anand Shah, deputy commissioner for medical and scientific Affairs, per a BioCentury report. The initiative, which launched in August, aims to figure out how Covid-19 policy can be improved.
Woodcock, along with Peter Marks, recused herself back in May after joining OWS when an advocacy group argued their roles close to the White House could pose a conflict of interest. Given that the pair were expected to help meet President Trump’s goal of having a vaccine by the November election, critics argued they were not the best judges of the data. — Max Gelman
NIH, Moderna study possibility of halving vaccine dose
It may be two months before Moderna and the NIH can conclude whether they can halve their vaccine dose and provide the same level of protection, thereby doubling the supply.
The idea was first brought to the fore by Moncef Slaoui, the head of Operation Warp Speed, who proposed slashing the Moderna vaccine dose from 100 μg to 50 μg based on data from a subgroup, aged 18 to 55, who received that regimen in a Phase II. But the FDA was much less enthusiastic about it, issuing a statement one day later to say that suggesting changes to the authorized dose and schedule is “premature.”
The stakes are high because with two emergency use authorizations so far, the US has ordered enough vaccines for only 185 million Americans out of 300 million. Vaccinations have lagged seriously behind federal projections of distributing 20 million doses by the end of 2020 — less than 5 million shots have been given so far — but once the current batches are used up, shortages could occur.
“The total supply of vaccine has always been a concern,” John Mascola, director of the NIH’s Vaccine Research Center, told the New York Times, “It’s important to do these analyses that we’re doing, and have all that data in our pocket in the event that there’s a need to use it.”
The FDA will have to sign off on any dosing changes.
A few other solutions have been floating around. Soon after Pfizer and BioNTech began rolling out their mRNA vaccine, pharmacists discovered that they could extract one, or sometimes two, more doses out of a vial even after getting the recommended 5 doses. The FDA quickly advised that those extra doses can be found as long as different vials aren’t mixed together.
Others — and the UK serves as the most notable example — have advocated for prioritizing getting the first doses to more people rather than making sure people get both doses on time.
Pfizer and BioNTech tested a regimen of two doses given 21 days apart in their Phase III trials. The UK initially recommended that the second shot be administered 21 to 28 days after the first, but it’s altered the guidelines to allow for a gap of up to 12 weeks — an approach spelled out in its authorization of another vaccine developed by AstraZeneca and Oxford.
Both Pfizer and BioNTech have said that there’s no evidence to support this alternative dosing schedule. On Tuesday, the WHO gave its recommendation of keeping the vaccinations within 21 to 28 days but added “a provision for countries in exceptional circumstances of (Pfizer) vaccine supply constraints to delay the administration of the second dose for a few weeks in order to maximise the number of individuals benefiting from a first dose.”
“We … totally acknowledge that countries may see needs to be even more flexible in terms of administration of the second dose,” Joachim Hombach, executive of WHO’s Strategic Advisory Group of Experts on Immunization, told reporters. “But it is important to note that there is very little … empirical data from the trials that underpin this type of recommendation.”
I have advocated vaccinating more folks quickly, worrying less if 2nd dose goes in a little late
Was asked twice today whether states should do this against FDA guidance
Let's persuade @US_FDA with debate, data
But undermining FDA would harm public health
— Ashish K. Jha, MD, MPH (@ashishkjha) January 5, 2021
Pfizer/BioNTech score new authorization in Colombia
Colombia has become the latest country to authorize the Pfizer/BioNTech Covid-19 vaccine for emergency use, paving the way for a rollout in February.
It’s struck a deal to buy 10 million doses of the vaccine, which would go first to those 60 or older with co-morbidities and health workers. The country has also secured shots from AstraZeneca/Oxford, Janssen and the COVAX coalition led by the WHO.
Mexico, Chile and Costa Rica were the first Latin American countries to start mass vaccination with the mRNA jab developed by the US and German partners. Meanwhile, Argentina opted for Russia’s adenovirus-based Sputnik V for its initial campaign and Brazil has pre-ordered from China’s Sinovac a vaccine that was being tested locally. — Amber Tong
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