Covid-19 roundup: AstraZeneca pauses vaccine trial for children as blood clot probe continues; EMA to investigate whether Sputnik V trials met GCP standards — report
AstraZeneca and partners at Oxford University have halted dosing of their Covid-19 vaccine to children in a small clinical trial in the latest hiccup caused by safety scares.
MHRA — the UK’s medicines regulator — has been conducting what they called a “thorough and detailed review” to investigate a possible link between the vaccine and rare blood clots in adults.
“Whilst there are no safety concerns in the paediatric clinical trial, we await additional information from the MHRA on its review of rare cases of thrombosis/thrombocytopaenia that have been reported in adults, before giving any further vaccinations in the trial,” Andrew Pollard, chief investigator of the trial, told the BBC.
Around 300 volunteers had signed up for the study, which started around mid-February. It’s unclear how many have already received the vaccine (or how many doses they got).
The acknowledgment of a pause comes after a top vaccine expert at the EMA said in an interview with Italian newspaper Il Messaggero that there is a “clear” association between the vaccines and thrombotic events, but the causes remain unknown.
It was the first time a health official publicly suggested a connection, following a tense few weeks of countries across Europe suspending use of the shot due to reports of blood clots.
Days ago, the EMA came out with “a clear scientific conclusion that this is a safe and effective vaccine,” and called for vaccinations to continue while countries raise awareness of these possible rare conditions. The agency is set to provide updated guidelines later in the week. — Amber Tong
EMA to investigate whether Sputnik V trials met GCP standards — report
As the EU struggles with vaccine rollout, the EMA will launch an investigation next week into whether Russia’s controversial Sputnik V vaccine meets “good clinical practice” (GCP) standards, the Financial Times reported.
Unnamed sources told the FT that the regulator is taking a deeper look due to concerns that the Sputnik V trials weren’t ethically run. Reuters has previously reported that state employees were pressured by their superiors to enroll in the trials.
One municipal officer, Sergei Martyanov, allegedly told colleagues to recruit friends and family in the trials, sending out the message: “At least two people per employee!” according to Reuters.
Kirill Dmitriev, head of the Russian Direct Investment Fund, denied the allegations to the FT. He said the vaccine has already been authorized in 59 countries, and that there was “no pressure [on participants] and Sputnik V complied with all clinical practices.”
Sputnik V became the world’s first registered Covid-19 vaccine back in August, when the country authorized the jab before it cleared Phase III trials. In February, researchers wrote in The Lancet that the vaccine had an efficacy rate of 91.6%, based on the number of Covid-19 cases tracked 21 days after the first dose was administered in a Phase III trial.
But last month, the head of the EMA’s management board advised EU countries to hold off on authorizing the vaccine while the EMA reviews its safety and efficacy, prompting the shot’s developers to demand an apology.
“We demand a public apology from EMA’s Christa Wirthumer-Hoche for her negative comments on EU states directly approving Sputnik V,” a post from the official Sputnik V Twitter account read. “Her comments raise serious questions about possible political interference in the ongoing EMA review.” — Nicole DeFeudis
This wasn’t the first time Emergent BioSolutions has tossed millions of vaccine doses — report
Days after Emergent BioSolutions lost control of its Baltimore plant for botching millions of Covid-19 vaccine doses, reports have emerged that this wasn’t the first time the company had to toss doses.
Last week, the feds directed J&J to take control of the plant after Emergent mixed up vaccines from J&J and AstraZeneca, wasting up to 15 million doses. Emergent was tagged for multiple operating violations.
But according to the New York Times, this has happened before. The news organization reported that Emergent threw out five lots of AstraZeneca’s vaccine between October and January — each containing 2 to 3 million doses — due to contamination or suspected contamination.
Audits viewed by the Times revealed that Emergent hadn’t followed basic industry standards at the Baltimore plant, as well as risks of viral cross-contamination, mold problems, and poor disinfection.
Emergent spokesperson Matt Hartwig told the Times the company was working with the feds to “address issues,” adding: “Any allegation that our safety, quality and compliance systems are not working or that we do not take these responsibilities seriously is false.”
The company has won more than $1.3 billion in contracts from the government as well as J&J and AstraZeneca to produce doses. — Nicole DeFeudis
CureVac co-founder calls out ‘US first’ supply chains for Covid-19 vaccine manufacturing disruptions in EU
For vaccine players in the EU looking to bring their Covid-19 jabs to market, a dearth of materials originating from US manufacturers has slowed production. Now, mRNA player CureVac’s co-founder is calling out an America-first manufacturing mandate for those shortages.
“Global supply chains are disrupted,” Florian von der Mülbe, who’s also CureVac’s chief production officer, said to the Rheinische Post. “Be it chemicals, equipment, filters or hoses: U.S. manufacturers are obliged first to meet American demand, and that means we are slipping down the list.”
Von der Mülbe added that vaccine makers looking to house production in Europe are at a disadvantage because suppliers in the US are required to cater to the home market at first under the Defense Production Act, according to Reuters. CureVac’s current production is based at its Tübingen, Germany plant.
In July, GlaxoSmithKline pledged to pump $293 million into the mRNA-based CureVac vaccine. The investment meant a big bet on mRNA as the core technology behind future vaccines and monoclonal antibodies. Perhaps most notably, that deal left CureVac responsible for manufacturing, all the way to the market.
CureVac has made efforts to stay ahead of the game as new Covid-19 variants have emerged. Two weeks ago, the company announced that it was expanding trial protocol for its Phase IIb/III in Europe and Latin America to determine efficacy for different strains of the virus. The company hopes to file for authorization in Europe in the second quarter.
Right now, CureVac has an alliance with Novartis to help manufacture the drug in Austria, with plans to produce up to 50 million doses by 2021. — Josh Sullivan
NIH to launch study on vaccine allergic reactions
The NIH on Wednesday announced that a clinical trial is underway to study allergic reactions to the Moderna and Pfizer-BioNTech vaccines.
The trial aims to determine whether those who are highly allergic or have a mast cell disorder are at increased risk to a reaction from the vaccine, a release from the NIH said. If an allergic reaction occurs in study participants, investigators will try to determine if a reaction is more common in these subjects than those with no allergy history.
“The information gathered during this trial will help doctors advise people who are highly allergic or have a mast cell disorder about the risks and benefits of receiving these two vaccines,” NIAID Director Anthony Fauci said in the statement. “However, for most people, the benefits of COVID-19 vaccination far outweigh the risks.”
The Phase II trial is sponsored and funded by the NIAID.
Following reports of early allergic reactions to the Pfizer-BioNTech vaccine in January, Moderna investigated one of its own vaccine batches for the same reason out of an “abundance of caution.” — Josh Sullivan
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