14 June 2021

• Novavax issues a press release with results from the 29,960- person, phase III PREVENT-19 trial of its coronavirus vaccine, NVX-CoV2373. Overall, the vaccine was 90.4 effective at preventing symptomatic COVID-19, and 100 percent effective against against moderate and severe disease COVID-19. There were 77 cases of COVID-19, 63 in the placebo group and 14 in the vaccine group, all mild. The vaccine was 93.2 percent effective against variants of concern (although the variants were not specified). The vaccine was 91 percent effective among people defined as “high-risk” – over age 65 or younger, with coexisting conditions or frequent exposures to COVID-19.

The company plans to file for regulatory approvals during Q3 of 2021, saying that it will be able to produce 100 million doses per month by the end of Q3, increasing to 150 million doses per month by the end of Q4, 2021. Source

• Public Health England issues a press release to announce that coronavirus vaccines are highly effective at prevention hospitalization from the Delta variant, based on an analysis of 14,019 cases of the Delta variant which occurred between 12 April and 4 June. Overall, full vaccination with the Pfizer/BioNTech vaccine was 96 percent effective at preventing hospitalization from Delta, and full vaccination with the Oxford-AstraZeneca vaccine was 92 percent effective, underscoring the importance of getting both doses. Source

• South African regulators reject two million doses of the J & J coronavirus vaccine which were produced in the country’s Aspen Pharmaceuticals plant after the US FDA declared that they were unsuitable for use due to possible contamination of the basic ingredients, which came from the troubled Emergent Biosolutions plant in Baltimore. Source

• The Washington Post publishes an analysis of vaccination rates and coronavirus cases in US states, finding rising case counts and significantly higher hospitalization rates in states with low immunization rates, while cases are markedly lower in states with high vaccination rates. The same held true within states, where most counties with low vaccination rates (under 20 percent of residents vaccinated) had high and growing case rates, and  most counties with high vaccination rates (at least 40 percent vaccinated) had low case rates which were falling. Experts fear summer surges “if the unvaccinated continue to behave as though they’re vaccinated,” said Dr. Michael Saag, an infectious disease specialist at the University of Alabama at Birmingham, adding that “For now, risk is unevenly distributed, concentrated in communities where shots are sparse.” Source

• British Prime Minister Boris Johnson announces that “Freedom Day”, when the country will lift remaining coronavirus restrictions, has been delayed from 21 June to at least 19 July, due to a surge of coronavirus cases driven by the Delta variant, which rose from 12,000 to 40,000 cases in one week. Source

• Stephen Saad, CEO of South Africa’s Aspen Pharmaceuticals, which performs ‘fill and finish’ for the J & J coronavirus vaccine, said that the company is sending 300,000 finished doses of the vaccine to the country in the coming days to make up for the loss of two million doses that had to be destroyed due to possible contamination at the Emergent Biosolutions plant which made the drug substance for the vaccine.  Source

• Marco Cavaleri, head of vaccine strategy at the EMA recommends that the EU avoid using the AstrZeneca coronavirus vaccine when alternatives are available, due to the risk of rare blood clots with low platelets; for the same reason he recommended that the J & J vaccine be used only in people over age 60. He noted that many countries in the EU are considering halting use of the AstraZeneca vaccines as availability of mRNA vaccines increases. Source

• Celltrion issues a press release, announcing that its experimental monoclonal antibody regdanvimab slowed severe COVID-19 symptoms in over 70 percent of patients and shortened recovery by nearly five days in a 1,135-person phase III trial. Source

• Bangkok’s Metropolitan Administration and dozens of hospitals across the country postponed some vaccinations this week amid reports of a shortage and supply constraints at AstraZeneca’s local manufacturing partner in Thailand. Source

• In Texas, a lawsuit by employees of Houston Methodist Hospital against a policy mandating staff coronavirus vaccines is dismissed by Judge Lynn M Hughes, who called the lawsuit’s contention that a vaccination requirement was similar medical experimentation during the Holocaust  “…reprehensible.” Source

• During an interview with the New York Times, leading Chinese virologist Shi Zhengli, known as “the bat woman,” expresses frustration about the accusations that her experiments with bat coronaviruses were too risky, and performed in biosafety level 2 labs, which might not have been safe enough; that employees of Wuhan’s Institute of Technology, were hospitalized with early cases of COVID-19 and that she held samples of the virus in her laboratory. “How on earth can I offer up evidence for something where there is no evidence? I don’t know how the world has come to this, constantly pouring filth on an innocent scientist.” Source

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