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Moderna clashes with US scientists over pivotal COVID-19 vaccine trials

Delays allegedly resulting from a lack of cooperation

Moderna

Moderna has clashed with US government scientists over pivotal large-scale trials of its COVID-19 vaccine, according to Reuters.

Moderna released the first batch of its COVID-19 vaccine, mRNA-1273, for human use in February, with the initial doses sent to the US National Institute of Allergy and Infectious Diseases (NIAID) to be used in a phase 1 study.

The US government is aiding the development of Moderna’s vaccine project with almost half a billion dollars in funding, and is one of the first to enter large-scale human trials. Moderna is also one of five drug companies that are part of the US government’s ‘Operation Warp Speed’, with the other four being Pfizer, Merck & Co, AstraZeneca and Johnson & Johnson.

The point of contention is that the other four companies are big pharma players, with a wealth of experience in conducting and running large-scale clinical trials. However, Moderna is a relatively young biotech company and sources familiar with the vaccine project told Reuters that the 'lack of staff and expertise' is a main source of the discord causing the delay of the critical human trials.

The sources added that Moderna has also allegedly argued with government scientists over the trial process, and has delayed delivering trial protocols and opposed experts’ advice on how to carry out the study. According to one of these sources, Moderna 'could be on schedule if they were more cooperative'.

Although Moderna has denied any wrongdoing, the company acknowledged that there were “differences of opinion” with experts involved in the project. “It has not been smooth or easy,” said Ray Jordan, a Moderna spokesman. “No one has ever done anything like this before – not Moderna, not the NIH and not any of the other companies.”

Despite the discord, Moderna is at the front of the race for the successful development of a COVID-19 vaccine. In May, Moderna announced positive phase 1 results for its vaccine, with participants in the study appearing to produce an immune response similar to that seen in those who had been infected with the virus and who had recovered.

Soon after the initial results had been revealed, Moderna said that it had dosed the first participants in phase 2 clinical trials, adding that it was finalising plans for phase 3 studies of the candidate to begin testing in July with 30,000 participants.

The recent news has now cast doubt on whether Moderna will still be able to begin that late-stage trial this month, although according to the US Department of Health and Human Services (HHS)  all companies involved in the government project have been “extremely cooperative” – including Moderna.

Article by
Lucy Parsons

8th July 2020

From: Regulatory

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