23 August 2021

• The US FDA grants full approval for the Pfizer/BioNTech coronavirus vaccine for people ages 16 and over (it will still be available under emergency use authorization for ages 12-15). The vaccine will be marketed as Comirnaty. The agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease. 

The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older. FDA  als conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis (an inflammation of the heart muscle) and pericarditis (inflammation of the tissue around the heart) following administration of the Pfizer-BioNTech vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. Source                      

• In Taiwan, where only three percent of the 23.5 residents are fully vaccinated, the first locally developed and produced coronavirus vaccine is now being administered, beginning with the country’s President, Tsai Ing-wen. More than half a million people have registered to get the vaccines, despite concerns that it is being used before effectiveness and safety have been proved in phase III trials. Source 

• Dr. Vivek Murthy, the US Surgeon General, issued a formal advisory warning about vaccine misinformation. Calling vaccine misinformation an “urgent threat” to public health. “The speed, scale and sophistication with which it is spreading and impacting our health is really unprecedented,” he said, adding that “…it’s happening largely, in part, aided and abetted by social media platforms. There are people who are superspreaders of misinformation and there are algorithms, still, which continue to serve up more and more misinformation to people who encounter it the first time. These are things that companies can and must change. And I think they have a moral responsibility to do so quickly and transparently.” Source 

• Lebanon’s hospitals are in crisis. The Rafik Hariri University Hospital, its largest public hospital, has had to rely on generators for days, and faces shortages of fuel, medicines and blood serum – and understaffing. At least 30 percent of  its doctors and more than 10 percent of its nurses have left – and many private hospitals, which offer 80 percent of Lebanon’s medical services, are shutting down because they lack  resources – or are turning away patients who can’t pay. Source  

• After a month of harsh measures, such as testing entire cities, quarantines, lockdowns and other restrictions to control the coronavirus, China reports zero cases. Source

• A pre-print article describes the generation and evolution of vaccine-induced immunity to SARS-CoV-2, including variants of concern, using 342 samples collected from 61 people who received mRNA vaccines at six timepoints (pre-vaccination baseline to six months post-vaccination), including people who had also recovered from SARS-CoV-2. They found that mRNA vaccines induced durable immune memory which continues to evolve over time by examining binding and neutralizing antibodies, memory B cells, and memory CD4+ and CD8+ T cells. Specifically, SARS-CoV-2-specific memory B cell responses were robustly induced following mRNA vaccination and continue to increase in frequency for at least six months, even while circulating antibody levels declined in the same person. Also, mRNA vaccination generated highly mutated memory B cells capable of cross-binding to variants including Alpha, Beta and Delta, which could also rapidly generate new antibody responses.  The researchers noted that potential discrepancies in vaccine efficacy at preventing infection versus severe disease, hospitalization and death may be due to declining antibody titers over time, which are likely to reduce the potential for sterilizing or near sterilizing immunity. Also, the durability of cellular immunity may contribute to rapid responses that prevent severe disease. They observed that boosting pre-existing immunity with mRNA vaccination mainly resulted in a transient benefit to antibody titers with little-to-no long-term impact on cellular immune memory. Source 

Return to the timeline