The end of 2020 witnessed two vaccine approvals in the US and UK. One expects to see more such approvals of other candidates in 2021. Meanwhile, two Asian countries have also made some new moves towards tackling the pandemic.
Korea Plans to Approve AZD1222 in 40 Days
The Ministry of Food and Drug Safety in Korea (MFDS) has announced the plan to approve the AstraZeneca/Oxford vaccine AZD1222 in 40 days compared to the original 180 days for rapid approval and review. The officials are expecting to kickstart the vaccination by the end of February.
As per the interim analysis of the Phase 3 trials published in The Lancet, the vaccine has shown high safety and efficacy in preventing COVID-19 against hospitalization or severe disease.
On November 23rd, AstraZeneca stated that AZD1222 reached the primary endpoint by demonstrating 70.4% effective with 2 doses. And a further analysis pointed out that comparing administering 2 doses, patients taking a half dose followed by a full dose showed 90% (n=2,741; CI 67.4% to 97.0%) of effectiveness and 62.1% (n=8,895; CI 41.0% to 75.7%) in patients given 2 full doses.
Patients after the first injection were not diagnosed with severe COVID-19 and were not hospitalized for more than 21 days.
Manufacturing Site and Clinical Data Review
Currently, AstraZeneca has put in two vaccine applications, one is manufactured locally by SK Bioscience while the other is imported from Italy, the US, and the UK.
Firstly, the ministry will review the submitted preliminary data and form a team with clinical trial experts to investigate the validity of non-clinical and clinical trial data. Later, the officials will investigate the site of manufacture.
“As on-site surveys are limited due to the Covid-19 situation, the ministry plans to confirm compliance with good clinical practice (GCP), such as the reliability of clinical trial results conducted overseas, through document review,” the ministry said. “Also, we plan to conduct a factory situation survey, including facility and environmental management and quality assurance system, to check the implementation status of the company’s good manufacturing practice (GMP).”
Japan Declares State of Emergency
To deal with the rising cases, Japan’s Prime Minister Yoshihide Suga has declared a state of emergency in Tokyo and three surrounding prefectures of Chiba, Saitama, and Kanagawa on Thursday.
The declaration includes the prohibition of restaurants and bars to open at late hours and financial support to those who comply. The declaration will not ask schools or the university entrance exam to switch to remote learning or stop but will call on companies to work remotely from their office.
The declaration will give more powers to the prefectural governors to encourage citizens to maintain social distancing and avoid going out after 8 pm and ask businesses to shut down or close early. What’s more, the local authorities are given permission to sway prices of daily essentials, etc.
It should be noted that compared to the lockdown in Europe or the US, citizens and businesses in Japan can refuse to cooperate, and no penalties are attached, but the government is planning on imposing penalties on businesses that don’t comply.
Suga said that the government will provide up to 1.8 million yen ($17,400) per month to each restaurant, which shortens its operating hours. Judging from past experience, most of the citizens are expected to follow the rules.
By Tyler Chen
Editor: Rajaneesh K. Gopinath, Ph.D.
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