AstraZeneca May Conduct Additional Covid-19 Vaccine Trial After Recognizing Errors In Initial Trial

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Topline

AstraZeneca will likely conduct further global trial of its Covid-19 vaccine candidate, says Bloomberg report, after questions were raised about the results of its trials – where the company said it was up to 90% effective in preventing the disease – and after the company admitted a manufacturing error.

AstraZeneca and Pfizer CEO give evidence to selection committee — Pascal Soriot, CEO of AstraZeneca, said the company will likely lead a new … [+] trial for its Covid-19 vaccine after recognizing a manufacturing problem had an impact on the previous trial.

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Highlights

The new trial would be conducted separately instead of adding a new arm to the ongoing U.S. trials of the vaccine and it would assess why people who received lower doses of the vaccine appear to have better protection against Covid-19, the Bloomberg report noted.

In an interview with BloombergAstraZeneca CEO Pascal Soriot said the company has now found what looks like a more effective dose and needs to validate it, “so we need to do an additional study,” which would be outside the States. United and faster because it would need a smaller number of patients.

Soriot acknowledged that the data from the new trial is unlikely to stand up to regulatory scrutiny in the UK and the EU, and noted that the US Food and Drug Administration (FDA) is also unlikely to approve a vaccine based on a study conducted outside the US

The company is, however, awaiting approval in some other countries before the end of 2020.

Large number

62%. This is the rate of effectiveness of the vaccine in people who have received two full doses of the AstraZeneca vaccine, the company said on Monday. Compared to that, 90% of people who received a lower initial dose – which the company recognized due to a manufacturing error – followed by a full dose were protected against Covid-19. Pfizer and Moderna have both announced that their vaccines are 95% and 94.5% effective in preventing disease.

Crucial quote

The AstraZeneca vaccine is also being tested in the United States and in his interview, Soriot acknowledged that the data from this trial would now be needed for US approval, saying, “The question for us was whether we will need US data to gain approval in the US. or can we get approval in the United States with international data, and that was never clear. Now, with these results, it’s more likely that we’ll need the US data. “

Key context

The vaccine developed by AstraZeneca and its partner the University of Oxford is a type of non-replicating viral vector that uses a harmless virus to stimulate a recipient’s immune system to develop antibodies. Compared to the mRNA vaccines from Pfizer and Moderna, AstraZeneca’s vaccine is easier and cheaper to manufacture, transport and store, which means it is more likely to be used worldwide. However, the botched trial data has led to concerns over whether the vaccine will be cleared by regulators. Moncef Slaoui, the head of the US government’s Operation Warp Speed vaccination program first revealed that the lower dose trial had been given to some people due to an error in the amount of vaccine placed in some vials and added that this part of the trial had been conducted. on a younger population, which the company failed to disclose in its Monday announcement. Soriot, however, took issue with the idea that the half-dose regimen was a mistake and claimed that once the researchers noticed the dosing error, they formally changed the testing protocol with the support of regulators. “I’m not going to tell you that we expected the efficiency to be higher,” Soriot said. Bloomberg. “People call it a mistake – it’s not a mistake.”

Chief critic

AstraZeneca’s stock surprisingly fell after its announcement after SVB investment bank analyst Leerink Geoffrey Porges wrote in an investor note that the company was “already clearly positioning the product as suitable for a market. use in less developed countries, where their relatively favorable storage conditions … may be advantageous. Porges added, “We believe this product will never be licensed in the United States,” said even Dr. Anthony Fauci, the country’s chief infectious disease officer. STAT news, “There is going to be a lot of hand waving” as people try to explain the results.