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Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #35

COVID-19 News early this week

We are going to have another busy week on the COVID-19 news front.

It started Tuesday December 8, with what U.K. officials dubbed “V-Day” whith the roll out of BioNTech/Pfizer BNT162B, their COVID-19 vaccine to public.  The first person to be vaccinated was Margaret Keenan, who turns 91 next week, at University Hospital in Coventry. “It is the best early birthday present I could wish for me” Keenan said. The second person to receive the vaccine, also at Coventry, was William Shakespeare who called the vaccine ”ground breaking” in a television interview.  The U.K. large-scale vaccination programme will see patients aged 80 and above who are already hospitalized or attending hospitals as  outpatients, among the first to be protected from contracting COVID-19 through vaccination. A small group of British citizens will be the first western subjects to receive a COVID-19 vaccine. 

On Saturday December 5, Russia began vaccination of thousands of physicians, care givers and teachers at dozens of selected centers in Moscow with its domestic Sputnik V vaccine.

Chinese SinoPharm vaccine, developed by Beijing Institute of Biological Products, has already been administered to hundreds of thousands of people under Emergency Use Administration in China but has not yet received public use approval in its home country.

Earlier today the United Arab Emirates Ministry of Health and Prevention announced that the SinoPharm vaccine was 86% effective in a phase III trial which included 31,000 subjects, with “no serious safety concerns”. The Chinese jab could be an attractive option for countries with inadequate cold-chain infrastructure and developing countries. Indonesia and Pakistan have already signed supply agreements with SinoPharm.

India has rejected AstraZeneca/Oxford’s COVID-19 vaccine “due to inadequate safety and efficacy data available currently” citing the news organisation NDTV. Serum Institute and Bharat Biotech have been asked for more data according to NDTV.

Roche and Moderna have announced a partnership to utilise FDA approved Elecsys anti SARS-CoV-2 antibody test in Moderna mRNA-1273 vaccine research trials. The test specifically detects antibodies against the SARS-CoV-2 spike protein. Measuring quantitative levels of SARS-CoV-2 antibodies will help gain valuable information into the correlation between protection from vaccination and antibody levels and play a major role in assessing when an individual needs revaccination.

Yesterday, the US FDA has released its internal document ahead of the Pfizer/BioNTech, BNT162b vaccine advisory committee planned for December 10. The report confirms the efficacy and safety profile of the vaccine. The reviewers stated that BNT162b development has “ensured the highest compliance and quality standards while progressing expeditiously” and the FDA staffers described the data as “highly effective protection against COVID-19 in a broad population of individuals across demographic characteristics” and… “support a positive assessment of risk and benefits for the BNT162b vaccine”.  Many analysts think the approval will be simple, straightforward and imminent just after the Vaccines and Related Biological Products Advisory Committee outcome on Thursday, December 10.

In a report published ahead of the World Health Organisation Big Event for Mental Health, it was shown that the impact of COVID-19 on mental health was devastating and that the pandemic has exacerbated mental health conditions of many people due to bereavement, isolation, loss of income, fear, anxiety and insomnia. “COVID-19 has interrupted essential mental health services around the world just when they are needed most” said Dr. Ghebreyesus, Director-General of WHO.

Paris, December 9, 2020.

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