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Disbelief intensifies with prolonged reports of side effects to the US FDA … “May be approved next January”
The reason for the high effect of ‘one and a half vaccination’ must also be identified.
The New York Times (NYT) said on the 8th (local time) that the vaccines at AstraZeneca and the University of Oxford in the UK, which were evaluated as the most advanced in the competition for vaccines against novel coronavirus infection ( Corona 19), lost the trust of the US health authorities and lagged behind in the approval competition. Reported.
AstraZeneca reportedly decided to stop the worldwide trial on September 6 due to unexplained side effects in clinical vaccine participants.
On September 8, two days after the decision, AstraZeneca did not address this fact during a telephone meeting with the US Food and Drug Administration (FDA) regarding emergency approval.
The FDA noted that it was suspended hours after the meeting ended and was very disappointed with AstraZeneca’s opacity.
The United States government was about to cover 60% of the required amount (around 300 million doses) from the company when AstraZeneca launched the vaccine in October, as stated.
This is because AstraZeneca has advantages over the vaccine developed by Pfizer and Modena in terms of price, distribution process and cost.
On September 9, the next day, AstraZeneca’s CEO tried to walk away by offering it in a closed-door meeting held by investor JPMorgan instead of revealing specific information about the side effects and clinical suspension to the public.
The United States government, which was evaluated as the closest to commercialization at the time, decided to invest $ 1 billion (about 1.1 trillion won) in the company’s vaccine development and production.
Health authorities in the UK, Brazil and India, where the company was in clinical trials, resumed the trials a week later, but continued to lag in the United States.
As a result, 30,000 people were not satisfied with the FDA’s vaccine approval criteria, and first-line clinical inoculators were unable to deliver the second dose.
The US government forced the resumption of national clinical trials in late October, a month and a half after this incident.
Earlier this month, the company’s clinical trials in the US were only conducted in half.
NYT noted that “AstraZeneca quickly submitted evidence to the FDA that the vaccine had no side effects, and because of this, clinical trials in the United States were halted for weeks.”
AstraZeneca’s management said on the 8th: “Given the response from the FDA, it is expected to be approved for use in the United States only when the results of clinical trials in the United States are published.”
NYT predicted this could be January of next year.
Not just in September, but also on July 12, AstraZeneca temporarily suspended the trial due to a neurological side effect in a clinical participant in the UK, but did not report it to the FDA, the NYT reported, citing internal sources.
AstraZeneca denied the NYT report and said it immediately provided all the information to the FDA.
Another reason that the commercialization of the AstraZeneca vaccine is lagging behind its competitors is because of the one and a half miracle, according to NYT.
This is because the efficacy was 62% when the vaccine was inoculated twice in full dose, but it showed greater than 90% efficacy when inoculated half at a time and the full dose twice.
AstraZeneca and the University of Oxford have yet to explain why.
NYT predicted that expedited FDA approval would be delayed if the cause of the difference in efficacy, which was accidentally obtained by manufacturer error, could not be medically identified.
Monsef Slawi, executive director of the US government’s ‘Operation SuperSpeed’, a team that oversees vaccine development, said: “Of the half of the vaccines that were highly effective, none of them were older than 55 years.” “I am concerned that it can be done.”
“If you don’t clearly explain why half the vaccine is more effective, it can be more difficult to approve it,” he said.
/ yunhap news
