British authorities approved the emergency use of the COVID-19 vaccine jointly developed by the pharmaceutical company AstraZeneca and Oxford University on December 30, but the U.S. Food and Drug Administration (FDA) is expected to approve emergency use only in April, two months later than expected. Came out. Monsef Slawi, the chief scientist of Donald Trump administration’s Corona 19 vaccine project,’Super-fast operation’, said at a press conference that “it will be possible in early April when everything goes well.” This vaccine is the same product that the Korean government decided to pre-purchase 20 million doses (for 10 million people) and introduce it in February and March.
FDA raises concerns over initial results of Phase 3
Ministry of Food and Drug Safety “Astra Preliminary Review”
Possibility of use prior to FDA approval
Government contracts with Modena for 20 million people
AstraZeneca is conducting additional clinical trials with 30,000 people in the United States, and a total of 27,000 people participated until last week. The company has always been a leader in the vaccine development process, but urgent use approval is delayed as the FDA raises concerns over the initial results of the phase 3 clinical trial. The New York Times (NYT) came up with an interpretation that the trust between the FDA and AstraZeneca was compromised.
In September of last year, AstraZeneca suspended the trial for investigation after a neurological disease, transverse myelitis, occurred in one of the subjects of a phase 3 clinical trial in the UK. However, two days later, during a regular meeting with the FDA, they did not inform them. NYT said, “I was embarrassed when FDA director Stephen Han later learned this through media reports.”
Transparency and information sharing are fundamental in the relationship between pharmaceutical companies and licensing authorities. In particular, AstraZeneca received US$1.2 billion (about 1.3 trillion won) in federal funds in the name of 300 million pre-purchases, R&D expenses, and expansion of production facilities from the super-high-speed operation team in May last year. Nevertheless, it is pointed out that trust would have been compromised by failing to fulfill the obligation to report faithfully to the FDA. After that, the FDA suspended clinical trials in the US for 7 weeks to investigate the cause, which significantly delayed the development schedule.
In addition, Pfizer and Modena vaccine showed 95% preventive effect, whereas AstraZeneca’s average effect was 70%. It is pointed out that because it is difficult to persuade the public to get a vaccine that is relatively ineffective, there is no justification or profit for the FDA to grant approval quickly unless a clinical trial shows a remarkably improved result. Commonwealth countries, such as Australia and India, are likely to grant emergency use of the AstraZeneca vaccine following the UK, but other countries are waiting only for a decision from the FDA.
The Korean government is in a position to consider whether this vaccine is used in Korea. On the 31st, the Ministry of Food and Drug Safety said, “We have been conducting a preliminary review of the AstraZeneca vaccine since October of last year, and will make our own judgment regardless of whether or not the foreign government approves it.” Accordingly, there is a growing possibility that this vaccine will be vaccinated with approval in Korea before the US approves it for emergency use. AstraZeneca is expected to apply for a permit in Korea in January.
Meanwhile, the Korea Centers for Disease Control and Prevention Commissioner Jeong Eun-kyung said, “We signed a contract with Modena to purchase 40 million doses of 20 million Corona 19 vaccines. It will be supplied to Korea from the second quarter.” Accordingly, the number of Corona 19 vaccines secured by Korea increased to 56 million people, including AstraZeneca, Janssen, and Pfizer. The government plans to announce a specific vaccination plan in January.
Washington = correspondent Park Hyun-young, reporter Esther and Hwang Soo-yeon [email protected]