Thursday, October 21, 2021

October 21: Johns Hopkins COVID 19 Report

COVID-19 Situation Report

Editor: Alyson Browett, MPH

Contributors: Clint Haines, MS; Natasha Kaushal, MSPH; Amanda Kobokovich, MPH; Christina Potter, MSPH; Matthew Shearer, MPH; Marc Trotochaud, MSPH; and, Rachel A. Vahey, MHS.

EPI UPDATE The WHO COVID-19 Dashboard reports 241.4 million cumulative cases and 4.91 million deaths worldwide as of October 20. Global weekly incidence decreased by 2.28% compared to the previous week, and mortality fell by 0.16%. These declines are smaller than those seen since mid-August, showing signs of stabilization.

Global Vaccination

The WHO reported 6.55 billion cumulative doses of SARS-CoV-2 vaccines administered globally as of October 19. A total of 3.7 billion individuals have received at least 1 dose, and 2.77 billion are fully vaccinated. Analysis from Our World in Data indicates that the overall trend in global daily vaccinations reached a recent low on October 17 at 20 million and is beginning to rise, up to 22.25 on October 20.* The global trend continues to closely follow Asia. Our World in Data estimates that there are 3.79 billion vaccinated individuals worldwide (1+ dose; 48.1% of the global population) and 2.88 billion who are fully vaccinated (36.58% of the global population).

*The average daily doses administered may exhibit a sharp decrease for the most recent data, particularly over the weekend, which indicates effects of reporting delays. In an effort to reflect the longer-term trends, the numbers reported here may not correspond to the most recent data.

UNITED STATES

The US CDC reports 45.07 million cumulative COVID-19 cases and 728,125 deaths. The current daily incidence average is approximately 75,988 new cases per day and appears to be decreasing. Daily mortality reached a recent low of 1,206 on October 17 but appears to be rising, up to 1,256 on October 19. Since August 13, 11.25 million fully vaccinated individuals have received a booster or additional dose of vaccine, including 15.3% of fully vaccinated adults aged 65 or older.

On October 15, the CDC began reporting hospitalization, infection, and death rates by vaccination status. For all adults aged 18 years and older, the cumulative COVID-19-associated hospitalization rate was about 12 times higher in unvaccinated persons between April 2021 and the end of August. In August, unvaccinated individuals were about 6 times more likely to test positive for SARS-CoV-2 and 11 times more likely to die of COVID-19 than those who were fully vaccinated. Notably, the COVID-19 case and death rates were slightly higher among J&J-Janssen vaccine recipients, followed by Pfizer-BioNTech recipients, and then Moderna. The incidence rate estimates are based on data collected from 16 health departments representing 30% of the US population.

*Changes in state-level reporting may affect the accuracy of recently reported data, particularly over weekends. In an effort to reflect the longer-term trends, the numbers reported here may not correspond to the most recent dates.

US Vaccination

The US has administered 410 million cumulative doses of SARS-CoV-2 vaccines. The daily vaccination trend rose briefly following authorization of booster doses of the Pfizer-BioNTech vaccine for some populations on September 22 but continues to decline after a recent peak on October 1*. A similar increase in the daily vaccination trend could occur in the coming months as booster doses likely will be made available for millions more people. There are 219.4 million individuals who have received at least 1 vaccine dose, equivalent to 66.1% of the entire US population. Among adults, 79.1% have received at least 1 dose, as well as 14.8 million adolescents aged 12-17 years. A total of 189.7 million individuals are fully vaccinated, which corresponds to 57.1% of the total population. Approximately 68.6% of adults are fully vaccinated, as well as 12.3 million adolescents aged 12-17 years.

*Due to delays in reporting, estimates for the average daily doses administered are less accurate for the most recent 5 days. The most current average provided here corresponds to 5 days ago.

VACCINE BOOSTERS As expected, the US FDA on October 20 authorized booster doses of the Moderna SARS-CoV-2 vaccine for certain populations and the J&J-Janssen vaccine for all recipients. The agency also authorized a “mix & match” booster strategy allowing the use of each of the available SARS-CoV-2 vaccines as a heterologous booster dose in eligible individuals who have completed their primary vaccination with a different vaccine. The FDA amended the EUA for the Moderna vaccine to allow for a single half-dose booster for fully vaccinated individuals at least 6 months from their second prime-boost dose who are also aged 65 or older, or aged 18 to 64 and at high risk of severe COVID-19, or aged 18 to 64 and have frequent institutional or occupational exposure to SARS-CoV-2. For the J&J-Janssen vaccine, the FDA authorized a single booster dose for all adult recipients at least 2 months after the primary shot. Additionally, the agency clarified the Pfizer-BioNTech authorization to allow it to be used for heterologous booster doses. The FDA already authorized boosters of the Pfizer-BioNTech vaccine for certain populations, and the companies today released topline results from a Phase 3 clinical trial showing a relative vaccine efficacy of 95.6% among booster dose recipients when compared with those who did not receive a booster. The data are not yet published or peer-reviewed.

In its communications, the FDA did not show preference for any of the vaccines and did not say whether it is better to receive a booster dose with the same vaccine. The US CDC’s Advisory Committee on Immunization Practices is scheduled to vote this afternoon on its own recommendations for the vaccine boosters. Notably, with various populations cleared to get boosters from different vaccines, and the FDA expected to soon authorize a different dose of the Pfizer-BioNTech vaccine for children ages 5 to 11, pharmacies, immunization programs, physicians, and others face challenges in tracking inventory, minimizing waste, and ensuring the correct dose is being given to the correct individual.

US PEDIATRIC VACCINATION PLANNING On October 20, the US White House released a plan for the rollout of SARS-CoV-2 vaccinations for children ages 5 to 11 when the US FDA and US CDC authorize their use. The largest parts of the plan involve the purchasing of 28 million doses of the Pfizer-BioNTech vaccine—enough to cover every child in that age group—and operational changes to make vaccination conveniently located and accessible. To support jurisdictional planning, the CDC published an Operational Planning Guide indicating that as soon as regulatory agencies make a decision, the US government will begin shipping pediatric vaccine formulations, initial allocations of which will be made pro-rata and are available for preorder. The White House plans to distribute the vaccines to 25,000 pediatrician offices and 100 children’s hospitals nationwide, in addition to sending doses to pharmacies and rural health clinics. Additional plans for public education will ramp up closer to the expected time of authorization, potentially the beginning of November. Speaking at a recent White House briefing, Dr. Anthony Fauci, Chief Medical Advisor to US President Joe Biden, reiterated the importance of achieving high vaccine coverage across all eligible age groups, noting data show that children can become infected with and transmit SARS-CoV-2 as readily as adults, although half of them remain asymptomatic.

UK & “DELTA PLUS” Late last week, the UK Health Security Agency released its 25th Technical Briefing on SARS-CoV-2 variants of concern and variants under investigation. Data on a new sublineage of the SARS-CoV-2 Delta variant—newly designated as AY4.2 and sometimes called “Delta Plus”—show incidence has been expanding within the country, accounting for 6% of all samples sequenced. Health officials expect this proportion to increase in the coming weeks, and many in the public health community are watching the sublineage to see how it impacts the COVID-19 epidemiological situation. The UK recently has experienced a drastic increase in new COVID-19 cases, reporting a daily average of 45,461 new cases on October 20, up more than 12,000 cases from 2 weeks ago. Additionally, the number of daily deaths are rising. Reports suggest that an increase in cases among children has been fueling this most recent spike, especially as this age group returned to schools. Notably, vaccine uptake has lagged since early September, although there has been an uptick in average daily vaccinations over the past several days. The UK has a higher vaccination rate than some of its European counterparts, with 79% of the eligible population fully vaccinated.

Public health experts are pleading with the UK government to reinstate COVID-19 restrictions that were rolled back this summer in order to avoid reaching a critical point where the virus becomes much more difficult to contain. The government has pushed back on these calls, saying the UK will not go back to a lockdown scenario and that people should “learn to live with this virus.” In September, Prime Minister Boris Johnson announced a “Plan B” for the country, to be implemented if the National Health Service (NHS) becomes overwhelmed. The plan includes reimplementing some restrictions like mask mandates and vaccine passports but would work to keep major operations running. Others are calling for a “Plan B Plus” that would go a few steps further and include urging people to get vaccinated or get boosters, using the healthcare system wisely, and volunteering to support frontline workers.

BRAZIL A parliamentary commission of inquiry (CPI) in Brazil is recommending that President Jair Bolsonaro be charged with 9 serious offenses—including charlatanism, incitement to commit crimes, the propagation of pathogenic germs, and crimes against humanity—for allegedly intentionally allowing the COVID-19 pandemic to spread unabated through the country and killing hundreds of thousands of people, according to a 1,180-page final draft of its report. The commission’s senators are scheduled to vote on the final report on October 26, and if approved, the accusation of crimes against humanity will be referred to the International Criminal Court for further investigation. The document also recommends criminal charges for at least 65 other people, including current and former government officials and 3 of President Bolsonaro’s sons. While it is unclear whether the accusations will lead to criminal charges, the report could prove damaging to President Bolsonaro’s reelection campaign. President Bolsonaro, a self-confessed vaccine skeptic, pushed unproven treatments, discouraged mask-wearing and encouraged mass gatherings as COVID-19 incidence increased nationwide. Of the 11-member committee, 7 are members of the opposition, suggesting the report will be approved.

MOLNUPIRAVIR Concerns are rising that access to Merck’s yet-to-be-authorized COVID-19 treatment will be limited for low- and middle-income countries (LMICs)—in ways similar to SARS-CoV-2 vaccines—leading the WHO and the Gates Foundation to make commitments to help improve access to the antiviral, called molnupiravir. In a draft document, the WHO-supported Access to COVID-19 Tools Accelerator (ACT-A) outlines plans to procure antiviral drugs to treat up to 120 million patients with mild COVID-19 for as little as $10 per course, although it does not specifically name molnupiravir. The Gates Foundation is committing US$120 million to support the production of generic versions of the still-experimental molnupiravir. Merck has already signed licensing agreements with at least 8 generic drug manufacturers, which will receive various types of incentives from the Gates Foundation to produce the drug as expeditiously as possible. Merck and its partner Ridgeback Biotherapeutics applied for Emergency Use Authorization (EUA) from the US FDA after releasing interim clinical trial results showing the drug cut COVID-19-related hospitalizations and deaths by about half. An FDA advisory committee is scheduled to meet on November 30 to discuss the companies’ EUA request. Although molnupiravir is easy to distribute and can be taken at home, price and availability likely will remain obstacles for poorer nations. Notably, several wealthy nations—including the US and at least 8 Asia-Pacific region nations—already have pre-purchase agreements for the antiviral, potentially setting the stage for access inequities to plague treatments in addition to vaccines.

GLOBAL VACCINE ACCESS The world continues to need more SARS-CoV-2 vaccines, especially in low-income countries that lack sufficient supplies, in part due to wealthy nations’ vaccine hoarding—including oftentimes secretive contracts between vaccine makers and governments—driving global inequalities. According to the International Federation of Pharmaceutical Manufacturers and Associations, global vaccine production is increasing and is expected to reach 12.5 billion doses by the end of 2021 and double to 24 billion doses by June 2022. But more production does not equal equitable distribution, and with many nations beginning vaccine booster initiatives, the onus lies on nations with excess supplies to donate those shots to countries in need. According to a new report from The People’s Vaccine alliance, only 14% of the 1.8 billion vaccine doses pledged for donation have been delivered to low- and middle-income countries (LMICs) to date, and pharmaceutical companies have delivered only 12% of the doses allocated to the COVAX initiative. Global health experts recently encouraged the US to donate its surplus doses, speed up the timeline for delivering the 1 billion doses of the Pfizer-BioNTech vaccine already promised, and use emergency powers under the Defense Production Act to increase vaccine production and force manufacturers to share technology with foreign producers. While the US International Development Finance Corporation is looking into supporting vaccine manufacturing and hubs in South Africa and India, those efforts are expected to produce 2 billion doses by the end of 2022, not quickly enough to meet current global demand.

In a POLITICO opinion piece, 2 senior EU officials warned the bloc is lagging in vaccine donations to LMICs, risking a loss of political influence as well as the emergence of new SARS-CoV-2 variants. Meanwhile, in a recent video address, Pope Francis encouraged vaccine makers to share their patents with producers in LMICs as a “gesture of humanity.” The pharmaceutical industry—along with the EU and other countries—continues to resist a proposal at the World Trade Organization (WTO) to implement a temporary waiver of intellectual property for COVID-19-related medical products, despite support from the US and around 100 other nations. Frustrated with the lack of cooperation, the WHO announced this week it has hired the South African pharmaceutical startup Afrigen Biologics and Vaccines to crack the code on Moderna’s mRNA SARS-CoV-2 vaccine in order to produce a generic version. If successful, Afrigen would serve as a “technology transfer hub,” essentially teaching other companies how to make the vaccine. Moderna, which has said it will not enforce its intellectual property during the pandemic and used US taxpayer funding to develop its vaccine, is under increasing pressure to share its technology.

Reportedly, India has delayed on its plan to resume vaccine exports to fulfill commitments to the COVAX initiative, which stopped in April, one day after the WHO requested additional data to make a decision on an emergency use listing for India’s homegrown vaccine Covaxin. The Serum Institute of India (SII) is contracted to supply hundreds of millions of doses of a version of the AstraZeneca-Oxford vaccine to COVAX and had said those shipments would resume this month.

HEALTH SYSTEM RESILIENCE The COVID-19 pandemic has had a profound impact on health systems worldwide, greatly affecting access to and quality of healthcare services. To better prepare for future pandemics, improve health systems, and work toward health-related Sustainable Development Goals (SDGs), the WHO released a position paper on and 7 recommendations for building resilience and strengthening health security within health systems. The paper calls for the international community and individual nations to invest in health systems, strengthen public health preparedness, and ensure political and public engagement to place health as a central tenet of socioeconomic recovery, growth, and resilience. At an event to launch the paper, Dr. Mike Ryan, Executive Director of the WHO Health Emergencies Programme, called for health to be viewed as an investment, not a cost, and spoke of the importance of thoughtful design in building resilient health systems. The WHO also published a brief highlighting key messages for government officials, leaders outside and within the health sector, and communities.

SEX OF FETUS New research indicates that the sex of a fetus may influence a pregnant person’s immune response when infected with SARS-CoV-2. In 2 studies published in Science Translational Medicine, researchers examined the immune responses of pregnant and lactating individuals to SARS-CoV-2 infection and vaccination, showing they mount robust antibody responses to both but could benefit from booster doses. In an interesting finding, one of the studies found that male placentas switched on more pro-inflammatory immune activation genes than placentas supporting female fetuses. Reduced maternal SARS-CoV-2 specific antibody titers and impaired placental antibody transfer also were seen in pregnancies of male fetuses. Sex-specific changes in both placental innate and humoral immunity indicated male vulnerability to maternal SARS-CoV-2 infection. The new data may provide insight on the previously reported sex differences among COVID-19 patients, including that, in general, males become more severely ill, are 3 times more likely to require intensive care admission, and also have higher odds of death than female patients.

Tuesday, October 19, 2021

October 19: Johns Hopkins COVID 19 Report

COVID-19 Situation Report

Editor: Alyson Browett, MPH

Contributors: Clint Haines, MS; Natasha Kaushal, MSPH; Amanda Kobokovich, MPH; Christina Potter, MSPH; Matthew Shearer, MPH; Marc Trotochaud, MSPH; and, Rachel A. Vahey, MHS.

BOOSTER DOSES The US FDA’s Vaccines and Related Biological Products Advisory Committee during 2 days of meetings last week considered several questions related to booster doses for SARS-CoV-2 vaccines. The panel’s recommendations are not binding, although the FDA generally follows the advice of its committees.

Moderna

The vaccine advisory panel on October 14 voted unanimously to endorse a booster dose of Moderna’s SARS-CoV-2 vaccine, administered at least 6 months after the second dose. The vote supports authorizing an additional dose of the vaccine in the same groups authorized for a booster dose of the Pfizer-BioNTech SARS-CoV-2 vaccine, including individuals aged 65 and older, those ages 18 to 64 at a higher risk for severe disease, and people at risk of exposure due to their occupation. The advisory panel also discussed when booster doses should be provided to all adults but concluded it is too soon to make that decision. The Moderna booster under consideration is 50μg, half the dose of the initial 2 shots, while the authorized booster for the Pfizer-BioNTech vaccine is the same formulation as the FDA-approved 2-dose vaccine. Moderna claims a half dose is enough to activate the immune system while still stretching the world's supply of available vaccines. Data from Moderna show that the booster dose did not produce the 4-fold antibody increase set as a guideline by the FDA for authorizing boosters, but Moderna said it was because of existing high levels of antibodies in study participants. Some panel members expressed concern over some of the data provided by Moderna—including on how best to measure correlates of protection and durability provided by a half dose—but not enough to prevent endorsement of booster doses. Others noted that avoiding public confusion over which vaccines were approved for booster doses and why played a role in their decision.

J&J-Janssen

During a second day of meetings on October 15, the vaccine advisory panel voted unanimously to endorse a second dose of the J&J-Janssen SARS-CoV-2 vaccine for all recipients. This meeting saw more controversy than previous meetings on booster shots for the Pfizer-BioNTech and Moderna SARS-CoV-2 vaccines, with some panelists reportedly unhappy with multiple slides presented by J&J-Janssen that contained data not previously vetted by the FDA. Additionally, the companies presented data on boosters given at 6 months from a study with a sample size of only 17 volunteers. Panelists expressed frustration with and hesitancy to make a decision based on the limited data, but all the panelists agreed that anyone who received the J&J-Janssen vaccine should be eligible for a second dose, with some saying the vaccine should be considered as a 2-dose regimen. The concerns revolved around data showing that a single dose of J&J-Janssen offered lower protection than 2 doses of either the Pfizer-BioNTech or Moderna vaccines.

Mix & Match

Following its vote on the J&J-Janssen vaccine, the panel discussed the so-called “mix & match” strategy, which could allow heterologous booster doses for certain populations. Data from an NIH study released last week showed that the antibody levels of those who initially received the J&J-Janssen shot rose 76-fold in 15 days following a booster with Moderna and 35-fold after a booster with Pfizer-BioNTech. By comparison, a second dose of J&J-Janssen only raised antibody levels 4-fold in the same timeframe. It is worth noting that there were concerns because the NIH study results were based on a small number of volunteers and only reported short-term findings. Despite these concerns, some panelists claimed the data are enough to convince them to support a mix & match strategy, something that is fairly common in other countries.

The FDA is expected to authorize boosters for some Moderna and all J&J-Janssen vaccine recipients as early as this week and also could make a decision on the mix & match strategy. The US CDC’s Advisory Committee on Immunization Practices (ACIP) is scheduled to meet this week to make its own recommendations on booster doses, meaning millions more people in the US could be eligible for additional shots by the end of the week.

MYOCARDITIS RISK The US FDA has delayed a decision on authorizing Moderna’s SARS-CoV-2 vaccine for adolescents ages 12-17 years to allow more time to scrutinize whether the vaccine is associated with an increased risk of myocarditis, an inflammatory heart condition, particularly among young males. The move comes after several Nordic countries paused the use of the Moderna vaccine for younger males, reportedly due to an increase in reports of myocarditis. A Moderna official said the company has requested data from those countries but has not yet received the information. The FDA has said the risk of myocarditis and pericarditis—inflammation of the heart’s lining—appears to be low following vaccination with either the Moderna or Pfizer-BioNTech vaccines, and that the benefits of the vaccines outweigh the risks. But most of that data come from the vaccines’ use among adults, and the agency appears to be taking extra caution in reviewing the data on adolescents. For parents eager to vaccinate their children, the delay in authorization could increase anxiety over safety concerns or assuage any hesitancy. The timing of the FDA’s decision on the Moderna vaccine is unclear, although regulators are working expeditiously. The Pfizer-BioNTech vaccine is available for use among people aged 12 and older in the US.

US CDC HOLIDAY GUIDANCE The US CDC on October 15 released new public health guidance for 2021 winter holiday celebrations, with a focus on urging those who are unvaccinated against SARS-CoV-2 to get their shots before traveling or gathering with family and friends. To protect those too young to be eligible for vaccination, the agency recommends all those around them to be vaccinated. According to new data released the same day, the CDC noted that in August, unvaccinated individuals had an 11 times greater risk of dying from COVID-19 than those who were fully vaccinated. Like 2020, the CDC also recommended masking when in crowded indoor settings and trying to be outside as much as possible in group settings. The new guidance was released following some confusion earlier this month, when the CDC mistakenly posted old information to its website. Some public health experts warned that as long as there are gaps in vaccination coverage throughout the country, a winter surge in COVID-19 cases remains a possibility, especially if people do not follow the guidance.

US NAVY The US Navy has formed a COVID Consolidated Disposition Authority to facilitate the administrative separation of Navy service members who refuse a SARS-CoV-2 vaccine without a pending or approved exemption. The Pentagon mandated vaccination for all service members in August, after the US FDA granted full approval to the Pfizer-BioNTech SARS-CoV-2 vaccine. According to an unclassified communication, more than 98% of active duty US Navy service members have begun or completed a vaccination series, and all active duty sailors must be fully vaccinated—defined as 2 weeks after completing an authorized or approved vaccine—by November 28. Those in the Navy Reserves must be fully vaccinated by December 28. Any sailor separated only for vaccine refusal will receive “no lower than a general discharge under honorable conditions,” which could mean losing some veterans’ benefits.

EUROPE SURGE COVID-19 is once again surging in Europe, particularly in the UK and Central and Eastern Europe. The daily incidence at the continent level increased by more than 45% since the most recent low on September 16. Over the past 2 weeks, 16 European countries have reported increases in daily incidence of 25% or greater, including Czechia (+102%), Latvia (+118%), and Poland (+123%) with greater than 100%. Additionally, Ireland and the UK reported increases of 23% and 20% over that period, respectively. Europe is exhibiting similar trends in terms of daily mortality as well, with 9 countries reporting biweekly increases of 50% or more, including Poland (+103%), Romania (+109%), and Luxembourg (+300%) with increases of more than 100%. With the exception of Iceland, Ireland, and the UK, nearly all of these countries are located in the Central and Eastern regions of Europe. As Europe transitions to colder weather and winter holidays, major COVID-19 surges could pose additional risk due to increased social activities and gatherings indoors.

Russia surpassed 30,000 new cases per day for the first time on October 17 and continues to set new records for daily incidence. Russia also continues to set new records in terms of daily mortality, now up to 967 deaths per day, more than 75% higher than the previous peak in late December 2020. Reportedly, some Russian researchers have accused the Russian government of manipulating the official data, and they argue that the true figures are much worse. According to a report by The Washington Post, Russia’s official COVID-19 mortality data may “exclude many deaths” that are determined to be a result of other conditions, potentially including those known to be associated with elevated risk of severe COVID-19 disease and death.

On October 18, Latvia announced a 4-week “lockdown” period, including the closure of schools, restaurants, retail stores, and entertainment venues. Only essential services and activities will be permitted during the lockdown, and essential employees who need to work in person are required to be vaccinated. Additionally, Latvia’s COVID-19 restrictions include a curfew from 8pm-5am, with limited exceptions for traveling to or from work or receiving medical care. All schools will remain closed through October 29, and in-person classes are scheduled to resume on November 1 for grades 1-3 and November 15 for grades 4-12. The Latvian government intends to begin relaxing the lockdown measures on November 15, but initially only in “green” areas (ie, those with lower SARS-CoV-2 transmission) and only for fully vaccinated individuals.

AFRICA The WHO Regional Office for Africa (AFRO) last week estimated that only about 1 in 7 COVID-19 cases is being detected on the continent and suggested the actual cumulative COVID-19 incidence in Africa as of October 10 was about 59 million, and not the 8 million cases in official reports. In order to get a better understanding of the pandemic in Africa, the WHO announced a new initiative aimed at increasing testing access in 8 countries, with the hopes of reaching as many as 7 million people with rapid diagnostic tests in the next year. Burundi, Côte d'Ivoire, the Democratic Republic of Congo, Guinea-Bissau, Mozambique, the Republic of Congo, Senegal, and Zambia will each receive US$1.8 million to scale up testing and preventive measures using a “ring strategy,” which focuses on providing voluntary testing, face masks, and hand sanitizer to people who live within 100 meters of a confirmed COVID-19 case. The strategy successfully helped to contain and eradicate smallpox from the continent in the late 1970s, and a ring vaccination strategy has been used to contain Ebola in recent outbreaks, so it will be interesting to see how the approach works with COVID-19.

Only about 5% of the total African population is vaccinated against SARS-CoV-2, with only 30% of the continent’s 54 nations having fully vaccinated 10% of their population. In a White House meeting with Kenya President Uhuru Kenyatta, US President Joe Biden on October 14 said the US will donate an additional 17 million doses of the J&J-Janssen vaccine to the African Union (AU). The donation, which is available for delivery immediately, adds to 50 million vaccine doses already donated by the US to the AU. However, the US donation is a drop in the bucket of what is needed. In September, WHO Africa estimated that an average 150 million doses need to be delivered to the continent each month if it is to fully vaccinate 70% of the population by September 2022.

SPUTNIK V People living with HIV are at elevated risk of severe or critical COVID-19 disease and death, according to the WHO. Additionally, some researchers have long warned that vaccines that use a specific adenovirus (Ad5) vector could increase the risk of contracting HIV among certain populations. The South African Health Product Regulatory Authority this week said it would not authorize Russia’s Sputnik V vaccine, which uses Ad5, over concerns it could increase the risk of HIV infection among males. The agency said the company that makes Sputnik V did not supply data showing the vaccine is safe when used in areas with high HIV prevalence. South Africa ranks first among all countries for the greatest number of people living with HIV. Notably, South Africa currently offers the J&J-Janssen vaccine—which also uses an adenovirus vector, albeit a different type (Ad26)—as well as the Pfizer-BioNTech and Chinese-made Sinovac vaccines. The Sputnik V vaccine is used in at least 50 countries worldwide but has not yet received emergency use listing status from the WHO.

EFFICACY OF INTERFERON The immunomodulator interferon beta-1a used together with the antiviral remdesivir was no better at treating hospitalized adults with COVID-19 pneumonia than remdesivir alone, according to the results of a study supported by the US NIH. Researchers assigned 969 patients recruited in 63 hospitals across 5 countries 1:1 to receive the study treatment plus remdesivir or a placebo plus remdesivir. According to the results, published online in The Lancet Respiratory Medicine, interferon plus remdesivir was not superior to remdesivir alone, and patients who were on high-flow oxygen at the beginning of the study and took interferon had worse outcomes compared with those who took only the antiviral, possibly due to interferon increasing their inflammatory response. 

ABBOTT TEST RECALL Abbott Molecular is recalling 2 of its SARS-CoV-2 laboratory test kits because they have the potential to issue false-positive results, and the US FDA classified it as a Class I recall—the most serious type of recall. The issue is related to the software used with the Alinity m SARS-CoV-2 AMP Kits and Alinity m Resp-4-Plex AMP Kits, and until the software can be updated, positive results should be treated as presumptive, according to the regulatory agency. The FDA previously warned clinical lab staff and healthcare providers of the potential for false positives and urged users to promptly report any adverse events associated with the tests.

Monday, October 18, 2021

10 Current Lawsuits against Trump

NBC News

Trump faces a pile of civil lawsuits as depositions begin

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Trump faces a pile of civil lawsuits as depositions begin

  • Donald Trump

Dareh Gregorian

Mon, October 18, 2021, 3:31 AM

In this article:

Former President Donald Trump has been ordered to answer questions under oath in a lawsuit Monday, and his attorneys could set a date for a deposition in another case, as well.

The lawsuits, involving allegations that his security guards roughed up protesters outside Trump Tower in New York and allegations of defamation by former "Apprentice" contestant Summer Zervos, respectively, are just two cases in the mass of civil litigation Trump faces post-presidency.

At least 10 civil cases are pending against Trump, whose ability to delay them has been curtailed since he left office in January. Trump had argued in some of the cases that as a sitting president he was immune from civil lawsuits. His office didn't respond to a request for comment on the cases.

Here's a rundown of where the major civil suits stand.

Summer Zervos

Zervos, a contestant on Season 5 of the reality show "The Apprentice," says Trump smeared her by calling her a liar during his 2016 presidential campaign after she accused him of having subjected her to unwanted kissing and groping when she was seeking career advice in 2007, a year after she appeared on the show.

An attorney for Trump declined to comment. Trump's attorneys have said that his statements were true and that they plan to file a countersuit.

At a court conference this month, the judge's law clerk said all depositions must be completed by Dec. 23.

"The defendant is now a private citizen, and he just cannot delay this litigation any longer," Zervos attorney Moira Penza told the clerk, according to The Associated Press.

Trump's attorneys could file court papers Monday to set a date for his deposition.

Protesters at Trump Tower

Also Monday, attorneys for protesters who allege that Trump's bodyguards assaulted them during a demonstration in 2015 were set to question Trump.

Trump said in an affidavit in 2016 that he has no knowledge about the altercation and that he wasn't directly involved in hiring security personnel. His attorneys tried to spare him from testifying for years, including while he was president, but the judge said his testimony was "indispensable."

The videotaped deposition was being conducted inside Trump Tower — where the six protesters were demonstrating in September 2015 over Trump' comments about Mexican immigrants when he was running for president — and they would be used as testimony when the case goes to trial.

E. Jean Carroll

Like Zervos, E. Jean Carroll is suing Trump for defamation, contending that he slandered her by accusing her of making up allegations of sexual assault. Carroll alleges that Trump raped her during a chance encounter in a New York City department store in the mid-1990s.

Trump countered that "she's not my type" and that the incident "never happened," and he accused her of concocting the story to sell her 2019 memoir, in which she recounted the allegation of assault. Carroll says she still has the dress from the encounter, and her attorney has asked for a DNA sample from Trump to help prove her claim.

The state case was transferred to federal court last year after the Justice Department sought to intervene, arguing that Trump was immune because the statements were part of his official responsibilities. The judge disagreed, a ruling that Trump and the Justice Department have appealed.

The 2nd U.S. Circuit Court of Appeals will hear arguments in December, and deposition dates could be set soon after the court rules.

Business investors

Trump, his children Eric, Don Jr. and Ivanka, and his company are also being sued in the same courthouse by a group of people who claim that the family conned them into making bad investments in businesses the Trumps were promoting. The suit, which seeks class-action status for thousands of people, alleges that Trump hid that he was being paid millions to endorse the companies.

"From 2005 to at least 2015, defendants received millions of dollars in secret payments to promote and endorse ACN," the suit alleges, referring to a multilevel marketing company that was among the businesses the Trumps were endorsing. "In return, Donald J. Trump told prospective investors that '[y]ou have a great opportunity before you at ACN without any of the risks most entrepreneurs have to take,' and that ACN's flagship videophone was doing 'half-a-billion dollars' worth of sales a year.' Trump also told investors that he had 'experienced the opportunity' and 'done a lot of research,' and that his endorsement was 'not for any money.' Not a word of this was true."

Trump's attorneys contended that the investors didn't have a case because none of them paid the Trumps directly, and they argued that the family isn't responsible for any of their losses. They also argued that Trump's statements were opinion and that they included "puffery" that no "reasonable investor" would have relied upon.

Depositions are supposed to be concluded by April 29, and the case is expected to go to trial in 2023.

Mary Trump

Trump and other family members face a fraud lawsuit from his niece Mary Trump, who alleges that the family defrauded her out of millions of dollars from her grandfather's estate.

"For Donald J. Trump, his sister Maryanne, and their late brother Robert, fraud was not just the family business — it was a way of life," her New York State Supreme Court lawsuit says.

The suit alleges that the trio cheated her out of her fair share of her grandfather's estate by presenting her with valuations that showed it was worth less than it was and by getting her and her brother, Fred Trump III, to sign a settlement agreement in 2001 based on the valuations. She said she concluded that she and her brother had been swindled in the settlement after an investigation into the family's finances by The New York Times in 2018. Donald Trump's siblings didn't respond to requests from The Times for comment about her allegations.

Attorneys for Trump and his siblings have asked a judge to dismiss the suit, contending that her time to pursue the claims has long since expired. They also pointed to Mary Trump's possession of the records she said she was misled about.

"[A]ll of the information that plaintiff claims was unknown to her until 2018 and which forms the basis of her alleged fraud claims, was plainly made known to her and her lawyer twenty years ago," Trump's team argued.

Trump has also filed his own suit against Mary Trump, alleging that she violated their settlement and a nondisclosure agreement.

Jan. 6

Trump has been hit with at least four lawsuits by Democratic lawmakers and Capitol Police officers over the Jan. 6 pro-Trump riot at the U.S. Capitol, which disrupted the official counting of electoral votes for president. The suits allege that Trump and other defendants violated the Ku Klux Klan Act of 1871, which one of the suits says "was intended to protect against conspiracies, through violence and intimidation, that sought to prevent members of Congress from discharging their official duties."

Trump's attorneys maintained that he is immune from the claims because he was president at the time and that his fiery speech at a rally on the morning of Jan. 6 was protected by the First Amendment. They want the cases dismissed. Depositions have yet to be scheduled.

Voting rights

The false claim underlying the Jan. 6 incitement allegations against Trump and his allies — that the 2020 election was "stolen" from Trump — is also at the center of another lawsuit that accuses Trump and his campaign of violating the Ku Klux Klan Act and the Voting Rights Act.

The NAACP and the Michigan Welfare Rights Organization say in the lawsuit, which was filed while Trump was challenging election results in numerous states, that Trump tried "to disenfranchise hundreds of thousands of voters" by pressuring state and local leaders not to certify election results.

"These systematic efforts — violations of the VRA and the Ku Klux Klan Act — have largely been directed at major metropolitan areas with large Black voter populations," the suit says. It seeks a declaration that he violated both laws and an order blocking him from coercing officials or obstructing voters in the future.

Trump's attorneys have asked that the case be tossed, saying the plaintiffs are trying to "improperly regulate constitutionally protected speech and to stymie President Trump's efforts to expose widespread voter integrity issues which operated to dilute the voices of voters in Michigan and throughout America."

Above is from:  https://www.yahoo.com/news/trump-faces-pile-civil-lawsuits-083100542.html