Coronavirus Tidbits #129 3/14/21

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Announcements:

First, there is now a Resources Page here for the most commonly asked questions I’m getting.

Happy to continue to answer your questions/concerns as best I can, so don’t be shy about that.

News 

Mutations and Pfizer vax

(Press release)  The Israel Ministry of Health (MoH), Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact of Israel’s nationwide immunization program. These new data build upon and confirm previously released data from the MoH demonstrating the vaccine’s effectiveness in preventing symptomatic SARS-CoV-2 infections, COVID-19 cases, hospitalizations, severe and critical hospitalizations, and deaths.

The latest analysis from the MoH proves that two weeks after the second vaccine dose protection is even stronger – vaccine effectiveness was at least 97% in preventing symptomatic disease, severe/critical disease and death. This comprehensive real-world evidence can be of importance to countries around the world as they advance their own vaccination campaigns one year after the World Health Organization (WHO) declared COVID-19 a pandemic.

The MoH analysis was conducted when more than 80% of tested specimens in Israel were variant B.1.1.7, providing real-world evidence of the effectiveness of BNT162b2 for prevention of COVID-19 infections, hospitalizations, and deaths due to variant B.1.1.7. However, this analysis was not able to evaluate vaccine effectiveness against B.1.351 (formerly referred to as the South African variant) due to the limited number of infections caused by this strain in Israel at the time the analysis was conducted.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210311005482/en/

https://www.pfizer.com/news/press-release/press-release-detail/real-world-evidence-confirms-high-effectiveness-pfizer

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Maryland’s Novavax COVID-19 Vaccine Confirms High Levels of Efficacy Against Variants

Novavax, Inc. announced the final efficacy of 96.4% against mild, moderate, and severe disease caused by the original COVID-19 strain in a pivotal Phase 3 trial in the United Kingdom of NVX‑CoV2373, the company’s vaccine candidate.

Novavax also announced the complete analysis of its Phase 2b trial in South Africa, with an efficacy of 55.4% among the HIV- negative trial participants in a region where the vast majority of strains are B1.351 escape variants.

Across both studies, the NVX-CoV2373 vaccine demonstrated 100% protection against severe COVID-19 disease, including all hospitalization and death.

https://www.precisionvaccinations.com/2021/03/11/marylands-covid-19-vaccine-confirms-high-levels-efficacy-against-variants

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Specialist trauma mental health services a necessity for UK healthcare staff after COVID

Almost 60% of UK frontline health and social care workers (HSCWs) experienced a mental health disorder during the first COVID-19 lockdown, with many of those surveyed suffering “very high rates of distress”, suggests a new study led by researchers at UCL and the University of Haifa, Israel.

Given the significantly high levels of mental health disorders across all HSCWs, the researchers believe the sector could be on “the verge of a mental health crisis” and are now calling for long-term planning to meet the needs of the staff, such as specialist trauma services, similar to the NHS psychological trauma provisions for military veterans.

https://www.eurekalert.org/pub_releases/2021-03/tfg-stm030921.php

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SARS-CoV-2 variants do not substantially affect CD4+ and CD8+ T cell responses, study shows

Researchers from California in the United States have conducted a study showing that important adaptive immune responses to infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are not affected by four recently emerged variants of the virus.

Several studies have demonstrated that mutations present in recently emerged variants of SARS-CoV-2 confer resistance to neutralizing antibodies (the humoral immune response) in sera from convalescent and vaccinated individuals.

This has highlighted the need to better understand adaptive immune responses to the virus, say researchers from La Jolla Institute for Immunology, the Craig Venter Institute in La Jolla, and the University of California in San Diego.

Now, the team has conducted a comprehensive analysis showing that CD4+ and CD8+ T cell responses in convalescent individuals and recipients of the Pfizer-BioNTech and Moderna COVID-19 vaccines are not substantially affected by mutations found in four recently emerged SARS-CoV-2 variants.

The variants tested included the B.1.1.7, B.1.351, P.1 and CAL.20C variants that have emerged over recent months in the UK, South Africa, Brazil and California, respectively.

https://www.news-medical.net/news/20210303/SARS-CoV-2-variants-do-not-substantially-affect-CD42b-and-CD82b-T-cell-responses-study-shows.aspx

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Ebola news–fascinating and disturbing

Diagnostics:

still an incredible, negligent lack of testing.

Drugs and Vaccines:

EU regulator says no signs AstraZeneca vaccine led to Austria illnesses

(Reuters) – The European Medicines Agency said on Wednesday there was no evidence so far linking AstraZeneca’s COVID-19 vaccine to illnesses in two people who received it in Austria, one of whom died 10 days after being inoculated.

The Austrian national health authority suspended the use of a batch of the vaccine after a person who was vaccinated was diagnosed with multiple thrombosis and later died, and another was hospitalised with pulmonary embolism.

 EMA’s statement. (bit.ly/3l1A0n0)

https://www.reuters.com/article/us-health-coronavirus-austria-vaccine/eu-regulator-says-no-signs-astrazeneca-vaccine-led-to-austria-illnesses-idUSKBN2B22AV?utm_source=

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Pakistan to Get 45 Million India-Made COVID Vaccines Through GAVI

Pakistan has inoculated 27.5 million people, including frontline health workers and elderly people, against COVID.

The Pakistan National Health Services announced on 5 March that the country is to receive 45 million ‘Made in India’ COVID vaccines this year through the Global Alliance for Vaccines and Immunisation, reported The Nation.

HOW WILL THIS WORK?

Pakistan will not receive the vaccine directly from India, but through its partnership with GAVI.

By June 2021, out of the total of 45 million, Pakistan is to receive 16 million free doses of Serum Institute of India-Oxford-AstraZeneca’s Covishield, which will cover 20 percent of Pakistan’s population, noted NHS secretary Aamir Ashraf Khawaja, reported Dawn.

The first batch of vaccines is due by mid-March and the rest by the end of June, reported Livemint.

https://www.thequint.com/news/world/pakistan-to-get-45-million-india-made-covid-vaccines-through-gavi

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Another new Rx for COVID-19 coming: VIR-7831 (GSK4182136)

California-based Vir Biotechnology, Inc. and GlaxoSmithKline plc announced that an Independent Data Monitoring Committee (IDMC) recommended that the Phase 3 COMET-ICE trial evaluating VIR-7831 (GSK4182136) as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrollment, due to evidence of profound efficacy.

The IDMC recommendation was based on an interim analysis of data from 583 patients enrolled in the COMET-ICE trial, which demonstrated an 85% reduction in hospitalization or death in patients receiving VIR-7831 as monotherapy compared to placebo.

As the trial remains ongoing and blinded with patients continuing to be followed for 24 weeks, additional results, including epidemiology and virology data, will be forthcoming once the trial is completed.

Based on these results, Vir and GSK plan to submit an Emergency Use Authorization application to the U.S. Food and Drug Administration (FDA) and other countries’ authorizations. Data from this registrational trial will also form the basis for a Biologics License Application (BLA) submission to the FDA.

The companies also announced today the results of a new study submitted and pending online publication in bioRxiv, demonstrating that VIR-7831 maintains activity against current circulating variants of concern, including the UK, South African, and Brazilian variants. In contrast to other monoclonal antibodies, VIR-7831 binds to a highly conserved epitope of the spike protein, making it more difficult for resistance to develop.

https://www.precisionvaccinations.com/2021/03/10/covid-19-monotherapy-study-stopped-due-evidence-profound-efficacy

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Aspirin use for cardiovascular disease may reduce likelihood of COVID-19 infection

The researchers analyzed data of 10,477 persons who had been tested for COVID-19 during the first COVID-19 wave in Israel from February 1, 2020 to June 30, 2020. Aspirin use to avoid the development of cardiovascular diseases in healthy individuals was associated with a 29% lower likelihood of COVID-19 infection, as compared to aspirin non-users. The proportion of patients treated with aspirin was significantly lower among the COVID-19-positive individuals, as compared to the COVID-19-negative ones. And those subjects who had been treated with aspirin were less associated with the likelihood of COVID-19 infection than those who were not. Moreover, the group observed that the conversion time of SARS-CoV-2 PCR test results from positive to negative among aspirin-using COVID-positive patients was significantly shorter, and the disease duration was two-three days shorter, depending upon the patients’ pre-existing conditions.

https://www.eurekalert.org/pub_releases/2021-03/bu-auf031021.php

Devices:

Epidemiology/Infection control:

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Nursing home visitation restrictions relaxed

According to the updated guidance, facilities should allow responsible indoor visitation at all times and for all residents, regardless of vaccination status of the resident, or visitor, unless certain scenarios arise that would limit visitation for:

https://www.cms.gov/newsroom/press-releases/cms-updates-nursing-home-guidance-revised-visitation-recommendations

Tips, general reading for public:

StayAtHome

Wash your hands.

Rinse and repeat.

Politics:

Patent rights

Rich, developing nations wrangle over COVID vaccine patents

GENEVA (Reuters) – Richer members of the World Trade Organization (WTO) blocked a push by over 80 developing countries on Wednesday to waive patent rights in an effort to boost production of COVID-19 vaccines for poor nations.

South Africa and India renewed their bid to waive rules of the WTO’s Trade-Related Aspects of Intellectual Property (TRIPS) agreement, a move that could allow generic or other manufacturers to make more vaccines.

South Africa argued the current TRIPS system does not work, pointing to the failure to secure life-saving medicines during the HIV/AIDS pandemic that had cost at least 11 million African lives.

Medecins Sans Frontieres in October put together a letter signed by over 375 civil society organisations supporting the waiver.

The South Africa and India proposal was backed by dozens of largely developing countries at the WTO, but opposed by Western countries, including Britain, Switzerland, EU nations and the United States, which have large domestic pharmaceutical industries.

India is a major manufacturer of generics, although many of the largest generic companies are based in Western and developed countries, including Viatris, Sandoz and Teva.

Western nations argue protecting intellectual property rights encouraged research and innovation and that suspending those rights would not result in a sudden surge of vaccine supply.

https://www.reuters.com/article/us-health-coronavirus-wto-idUSKBN2B21V9?

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https://twitter.com/yashar/status/1370051671858900995?s=20

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Feel good du jour:

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https://twitter.com/FeelGoodPage11/status/1370748069138952193?s=20

Comic relief:

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While it sounds peculiar, I found this thread quite amusing. Start here:

Perspective

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Bits of beauty:

 

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