• Israel’s Ministry of Health issues a press release announcing a “marked decrease” in efficacy of the Pfizer/BioNTech vaccine since 6 June, when the Delta variant began spreading in the country. The vaccine was 64 percent effective in preventing infection, and 64 percent effective at preventing illness from COVID-19, although it remained 93 percent effective at preventing serious illness and hospitalization. Source

• Israel is shipping 700,000 doses of the Pfizer/BioNTech coronavirus vaccine to South Korea, where there is a surge of new infections. South Korea will return the doses to Israel as early as Q3 of 2021. Source

• The WHO announces that it has updated guidelines for patient care to recommend the interleukin-6 receptor blockers tocilizumab and sarilumab for people who are severely or critically ill with COVID-19, especially when co-administered with corticosteroids. These medicines reduced the odds of death among severely and critically ill patients by 13 percent, and the odds of mechanical ventilation by 28 percent. 

“These drugs offer hope for patients and families who are suffering from the devastating impact of severe and critical COVID-19. But IL-6 receptor blockers remain inaccessible and unaffordable for the majority of the world,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus, adding “The inequitable distribution of vaccines means that people in low- and middle-income countries are most susceptible to severe forms of COVID-19. So, the greatest need for these drugs is in countries that currently have the least access. We must urgently change this.” 

WHO is calling on manufacturers to reduce prices and make supplies available to low- and middle-income countries, especially where COVID-19 is surging, through transparent, non-exclusive voluntary licensing agreements using the C-TAP platform and the Medicines Patent Pool, or to waive exclusivity rights. WHO has also launched an expression of interest for prequalification of manufacturers of interleukin-6 receptor blocker to meet urgent public health needs for these products. Source

• Strive Masiyiwa, the African Union’s Special Envoy on COVID-19, says that if J & J “make good” on its promise to ship 400 million doses of its coronavirus vaccine and COVAX provides 700 million doses of single- and double-dose coronavirus vaccines, Africa and the Caribbean could meet their 60 percent vaccination targets. Source 

• The US CDC publishes an analysis of the benefit-risk balance for mRNA coronavirus vaccines. Although benefits outweighed risks across all age groups, the balance differed by age and sex. Myocarditis (an inflammation of the heart muscle) occurring among young vaccinated males (age <30 years), usually after the second dose, and the increased risk of poor outcomes from COVID-19 that comes with aging, influence this balance. 

The analysis revealed that every million second dose of an mRNA coronavirus vaccine given to males ages 12-29 could prevent 11,000 cases of COVID-19, 560 hospitalizations, 138 ICU admissions and six deaths, versus 39-47 expected cases of myocarditis. In males over age 30, a million second doses of an mRNA vaccine could prevent 15,300 cases of COVID-19, 4,598 hospitalizations, 1,242 ICU admissions, and 700 deaths, versus 3-4 expected cases of myocarditis. (Other potential benefits of COVID-19 prevention, such as avoiding prolonged symptoms, were not included in the analysis). Source 

• The African Union and Africa’s CDC announced that 15 million doses of coronavirus vaccines (five million are the J & J single-dose vaccine and the remaining ten million are the Pfizer/BioNTech vaccine) doses have been donated by the US and will be distributed by COVAX. Source

• Shareholders are filing suits against, and asking for their money back from Emergent Biosolutions, the company that ruined 75 million doses of coronavirus vaccines. The Lincolnshire Police Pension Fund has filed a complaint against the company’s executives and board members — including several former federal officials — claiming that they sold more than $20 million worth of stock over the past 15 months  “while in possession of material, nonpublic information that artificially inflated the price” and “profited from their misconduct and were unjustly enriched through their exploitation of material and adverse inside information.” Source

• The number of people held in US immigration detention centers has nearly doubled since April, from 14,000 to 26,000 – as coronavirus cases among the largely unvaccinated detainees have surged, reaching 7,500 during the same period. The US Immigration and Customs Enforcement agency leaves decisions about vaccinating detainees to state and local officials, and although new detainees are tested and held in quarantine, they are transferred between facilities in buses, without protection. Source

• India’s Minister of Health, Dr. Harsh Vardhan, steps down in the wake of intense criticism about the government’s mismanagement of the pandemic. “Mr. Modi was the face of the fight against Covid, so I think he has made Harsh Vardhan the scapegoat,” said Arati Jerath,  political analyst and writer.

Mansukh Mandaviya, minister of state for chemicals and fertilizers, has been appointed to replace Dr. Vardhan. Source

Nature publishes an analysis of the inclusion of data by sex/gender across 4,420 SARS-CoV-2 clinical trials registered between 1 January 2020 and 26 January 2021, noting sex and gender differences in incidence of and mortality from COVID-19, as well as type, frequency and severity of side effects. Overall they reported that only 178 ( 4 percent) included a plan to include an analysis by sex/gender and just eight of 45 COVID-19 related clinical trials (17.8 percent ) published until 15 December, 2020 reported sex-disaggregated results or subgroup analyses. The authors urge researchers to “…systematically apply a sex-specific methodology. This entails: (a) the recording of sex of all participants; (b) the inclusion of sex as an independent variable into multivariate analysis; (c) the performance of sex-disaggregated analyses; and (d) the reporting of sex-disaggregated results for unambiguous identification of differences in effectiveness, side effects, and mortality,” adding that intersectional approaches are needed to identify experiences of specific subgroups, including access barriers. Source

PLOS Medicine publishes a modeling study which found that antiviral treatment trials can be much smaller if people are enrolled immediately after experiencing symptoms of COVID-19. The authors suggest basing inclusion criteria on symptom onset and recruiting people as soon as possible. Source