AstraZeneca vaccine

Wealthy Western countries which are buying up the other highly effective vaccines, are going to push these off on the poor countries, aren't they?

Pharmaceutical company AstraZeneca has released additional data that it said confirms the efficacy of its Covid-19 vaccine after questions about interim clinical trial results were raised in the US by an independent agency. But the additional data suggests the vaccine is slightly – but not significantly – less effective than the interim results suggested.

Interim results released by AstraZeneca on Monday from the phase-3 clinical trial of more than 32,000 people found the vaccine was 79% effective against symptomatic disease and 100% effective against severe disease and death. But soon after the results were published, the Data and Safety Monitoring Board in the US said it was concerned AstraZeneca may have provided “outdated information” from the trial, which gave “an incomplete view” of the results.

  Guardian

Well, guess what? Suddenly AstraZeneca found additional data. Like those additional votes Trump complained about.

This means there is a 95% chance that the true efficacy of the vaccine is between 68% to 82%, making it similar to other vaccines including Pfizer’s.

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“We heard very positive news almost a week ago that the European Medical Authority’s safety committee concluded that the vaccine was not associated with an increase in the overall risk of blood clots and therefore the benefits of receiving the vaccine continue to outweigh the risk of side effects.”

Uh-huh. It's good enough for the poor countries.

That'll dip the stock market

AstraZeneca Plc is likely to conduct an additional global trial to assess the efficacy of its Covid-19 vaccine, according to the company’s chief executive officer, after current studies raised questions over its level of protection.

The new trial would be run instead of adding an arm to an ongoing U.S. trial and would evaluate a lower dosage that performed better than a full amount in Astra’s studies. The company’s acknowledgment that the lower level was given in error fueled concerns, and the new trial would be used to confirm whether or not the higher 90% efficacy rate stands.

  Bloomberg

Shit happens when you're rushed.

Soriot said he didn’t expect the additional trial to hold up regulatory approvals in the U.K. and European Union. Clearance from the U.S. Food and Drug Administration may take longer because the regulator is unlikely to approve the vaccine on the basis of studies conducted elsewhere, especially given the questions over the results, he said.

Vaccine testing snag

One of the leading coronavirus vaccine clinical trials, from AstraZeneca, has been paused to investigate a “potentially unexplained illness” in one of the participants, the company said Tuesday.

The announcement could lead to a concerning setback to a high-profile coronavirus vaccine clinical trial, though much remains unknown, and it is not clear how much of an impediment the development will be.

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The statement said it is possible the illness in one of the participants in the trial is not even caused by the vaccine. “In large trials illnesses will happen by chance but must be independently reviewed to check this carefully,” the company said. “We are working to expedite the review of the single event to minimise any potential impact on the trial timeline.” Stat, which first reported the pause in the trial, reported that the participant who had the “suspected serious adverse reaction” is in the United Kingdom.

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AstraZeneca is one of three companies that have phase three coronavirus vaccine trials ongoing in the United States. Two other trials are being conducted for potential vaccines from Pfizer and Moderna.

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The announcement illustrates the importance of a careful vaccine process to check safety and efficacy, and comes on the same day that AstraZeneca, as well as eight other drug companies, issued a rare joint statement pledging to follow the science and avoid politics, amid President Trump floating the idea of a pre-election approval of a vaccine.

  The Hill

The nature of the adverse reaction and when it happened were also not immediately known, though the participant is expected to recover, according to an individual familiar with the matter.

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There are a number of different reactions that can qualify as suspected serious adverse reactions, symptoms that require hospitalization, life-threatening illness and even death. It was also not immediately clear which clinical trial the adverse reaction occurred in, though a clear possibility is the Phase 2/3 trial underway in the U.K.

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Researchers running other trials are now looking for similar cases of adverse reactions by combing through databases reviewed by a so-called Data and Safety Monitoring Board, the second person said.

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The vaccine — known as AZD1222 — uses an adenovirus that carries a gene for one of the proteins in SARS-CoV-2, the virus that causes Covid-19. The adenovirus is designed to induce the immune system to generate a protective response against SARS-2. The platform has not been used in an approved vaccine, but has been tested in experimental vaccines against other viruses, including the Ebola virus.

  Stat News