Covid-19 roundup: EC strikes deals with Pfizer, Moderna for another 350 million vaccine doses; UK ethics body OKs challenge trial
The European Commission has inked deals with Moderna and Pfizer for a total of 350 million more vaccine doses, to be delivered throughout 2021.
It’s unclear how much the EC is paying for any of the doses. Moderna has promised to deliver 150 million more doses in Q3 and Q4, bringing the biotech’s total commitment up to 310 million doses in 2021. As part of the new agreement, the EU also holds the option to buy another 150 million doses for delivery in 2022.
“Moderna is committed to working relentlessly to bring to market vaccine boosts with the relevant variants to address this global pandemic,” CEO Stéphane Bancel said in a statement.
The EC also struck a deal for 200 million more doses of Pfizer and BioNTech’s vaccine, even as complaints about distribution lags surface across the bloc.
The additional doses will bring the EU’s total supply up to 500 million doses of the vaccine, which is marketed as Comirnaty in Europe — a combination of the terms Covid-19, mRNA, community and immunity. The EU holds the option to request another 100 million more doses down the road.
The 200 million doses will be delivered in 2021, with an estimated 75 million coming in Q2. It’s unclear how much the EC paid for the additional doses.
“With this new agreement with the European Commission, we now expect to deliver enough doses to vaccinate at least 250 million Europeans before the end of the year,” Pfizer CEO Albert Bourla said in a statement.
The announcement comes less than a week after President Joe Biden said his administration has purchased another 100 million doses from Pfizer, bringing its commitment up to 300 million doses. The US government also purchased another 100 million doses of Moderna’s vaccine, which are scheduled to arrive by the end of July.
Multiple countries in the EU have issued complaints about the distribution of Pfizer/BioNTech vaccines, including Italy, which threatened legal action more than once. After their vaccine supply was cut, the Italian government sent a formal letter of notice to Pfizer back in January, urging them to comply with contractual commitments for vaccine delivery, according to Reuters. Germany’s Hamburg has also complained of smaller shipments — and said they’re having trouble extracting a full six doses from vials.
Sweden, on the other hand, said it would refuse to pay Pfizer and BioNTech until they clarified with the EU how many chargeable doses are in a vial. The country said it was charged for six doses per vial instead of five as they initially agreed, and the sixth dose is impossible to extract without a special syringe. Pfizer and BioNTech officially changed their label in late January to account for a sixth dose in each vial.
Several other biotechs are jumping in to assist Pfizer and BioNTech with development, including Merck KGaA, which says it can accelerate its supply of custom lipids to BioNTech. Novartis has also agreed to lend a hand with development, and Sanofi has offered the use of its Frankfurt plant to produce more than 100 million doses. — Nicole DeFeudis
UK ethics body approves challenge trial
Covid-19 challenge trials are one step closer to arriving.
The UK government has given its stamp of approval on what would be the world’s first Covid-19 human challenge trial, as the nation’s clinical trials ethics body gave the thumbs-up on Wednesday. Britain will officially launch the trial within a month and has been preparing for the studies since last October.
“While there has been very positive progress in vaccine development, we want to find the best and most effective vaccines for use over the longer term,” UK business secretary Kwasi Kwarteng said in a statement. “These human challenge studies will take place here in the UK and will help accelerate scientists’ knowledge of how coronavirus affects people and could eventually further the rapid development of vaccines.”
Researchers plan to recruit up to 90 young and healthy volunteers aged 18 to 30 years old, who will be exposed to the virus in a controlled setting in an effort to determine the lowest possible virus amount needed to cause infection. Vaccines could then be given to a small number of volunteers before being exposed to the virus.
British officials did not say which vaccine might be used, only those that have proven safe in clinical trials. So far, the UK has OK’ed three vaccines for use: Pfizer/BioNTech’s vaccine, Moderna’s jab and AstraZeneca/Oxford’s shot.
In order to limit the risk to these individuals, Britain plans to use the original strain of SARS-CoV-2 that first began circulating in March, rather than any of the new virus variants.
The study is being run in collaboration with the UK government’s Vaccines Taskforce, Imperial College London, the Royal Free London NHS Foundation Trust and the company hVIVO.
Debate over the challenge trials has been ongoing since the start of the pandemic. Proponents argue that they aren’t any different than waiting for volunteers to get infected in a large-scale pivotal trial.
But critics say testing the trials won’t be representative of the most severe cases because of the age of volunteers, and exposing them to the virus can still pose a risk. And unlike challenge trials in other diseases, there are few, if any, “rescue therapies” available should patients fall seriously ill. — Max Gelman
Tillman Gerngross enters PhI with new monoclonal antibody candidate
Another monoclonal antibody treatment — this one from the lab of legendary Tillman Gerngross — has entered the clinic.
Adagio Therapeutics shared the news on Tuesday that it dosed the first patient in a Phase I trial for its lead antibody candidate, ADG20. That’s right on track with a plan Gerngross laid out in July, shortly after he raised $50 million to launch the biotech.
The CEO said that he was aiming for a drug that can be dosed twice a year with 90% efficacy — enough to create and maintain herd immunity while holding its own against anything else that may hit the market.
The Phase I trial will study ADG20’s safety and tolerability, as well as pharmacokinetics. Once safety data are evaluated, Adagio plans on launching global pivotal trials to assess its ability to treat and prevent Covid-19 infection.
“We are in the unique position of having a monoclonal antibody that binds to and protects against common circulating SARS-CoV-2 variants as well as SARS-related viruses with pandemic potential,” Gerngross said in a statement. “This broadly neutralizing activity was intentionally designed into ADG20, as we anticipated the continued emergence of resistance mutations, and we took deliberate steps to engineer ADG20 to maximize its potential to avoid viral escape.” — Nicole DeFeudis