US Government makes available more COVID-⁠19 test kits for free

Every U.S. household may again place an order to receive four free COVID-⁠19 rapid antigen tests to be delivered at no extra cost. The order can be placed at COVIDtests.com. A similar distribution was also done in January 2022 which I had written about here.

https://web.archive.org/web/20230925153653/https://www.covid.gov/tests

WHO ends global health emergency declaration for COVID-19

The World Health Organization has lifted the Public Health Emergency of International Concern (PHEIC) for COVID-19.

https://www.npr.org/sections/goatsandsoda/2023/05/05/1174269442/who-ends-global-health-emergency-declaration-for-covid-19

Theranos founder Elizabeth Holmes sentenced to more than 11 years in prison

Theranos founder Elizabeth Holmes was sentenced by the U.S. District Court for the Northern District of California to more than 11 years in prison for fraud after deceiving investors about the purported efficacy of her company’s blood-testing technology. She was ordered to surrender on April 27. Once valued at $9 billion by private investors, Theranos shut down in 2018.

https://www.cnbc.com/2022/11/18/former-theranos-ceo-elizabeth-holmes-sentenced-to-more-than-11-years-in-prison.html

Chartr in September 2021 while sharing a chart on the Rise & Fall of Theranos wrote: Elizabeth Holmes' grand vision was in blood testing. Theranos supposedly developed, or would develop, a way to run 200+ medical tests, from just a few drops of blood. That pitch ended up raising millions in funding, each round building hype and expectation that saw Holmes meet world leaders, go on TV and amass a personal fortune of $4.5bn+ on paper, as Theranos reached a dizzying $9bn valuation in early 2014.

Theranos founder Elizabeth Holmes sentenced to more than 11 years in prison

Theranos founder Elizabeth Holmes was sentenced Friday to more than 11 years in prison for fraud after deceiving investors about the purported efficacy of her company’s blood-testing technology.

https://www.cnbc.com/2022/11/18/former-theranos-ceo-elizabeth-holmes-sentenced-to-more-than-11-years-in-prison.html

Moderna’s Covid-19 vaccine receives full FDA approval

The vaccine, named Spikevax, is now approved for use in people ages 18 and older. It is not approved or authorized for use in younger individuals. There’s no difference between the approved vaccine and the vaccine previously available through emergency use authorization.

Moderna’s is the second Covid-19 vaccine to receive full approval from the FDA. Pfizer’s Covid-19 vaccine, Comirnaty, was approved for use in people age 16 and older in August. The Pfizer vaccine is also authorized for use in individuals ages 5 to 15.

https://edition.cnn.com/2022/01/31/health/moderna-covid-vaccine-fda-approval/index.html

US Government makes available 4 free COVID-⁠19 test kits per household

The US Government is making available 4 free packs of rapid antigen (not PCR) COVID-⁠19 test kits per address which will be delivered for free. The kits can be ordered from COVIDtests.gov.

https://web.archive.org/web/20220119105823/https://www.covidtests.gov/

FDA Authorizes First Oral Antiviral for Treatment of COVID-19

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19

Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S.

Johnson & Johnson today announced new data reinforcing the strong and long-lasting protection of its COVID-19 vaccine. New data also showed that protection against COVID-19 increases when a booster shot of the Johnson & Johnson vaccine is administered. The safety profile of the vaccine remained consistent and was generally well-tolerated when administered as a booster.

https://www.jnj.com/johnson-johnson-announces-real-world-evidence-and-phase-3-data-confirming-strong-and-long-lasting-protection-of-single-shot-covid-19-vaccine-in-the-u-s

Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years

Pfizer Inc. and BioNTech SE today announced results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older.

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results

FDA grants Pfizer COVID-19 vaccine full approval

The Food and Drug Administration (FDA) on Monday granted full approval to Pfizer's COVID-19 vaccine for individuals 16 years and older. This makes the Pfizer vaccine the first COVID-19 shot to receive full approval, beyond emergency use authorization.

https://www.foxbusiness.com/healthcare/fda-grants-pfizer-covid-19-vaccine-full-approval

FDA Approves First COVID-19 Vaccine

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

Vaccines still effective against Delta variant of concern, says Oxford-led study of the COVID-19 Infections Survey

Two doses of either vaccine, Pfizer-BioNTech or Oxford-AstraZeneca, still provided at least the same level of protection as having had COVID-19 before through natural infection; people who had been vaccinated after already being infected with COVID-19 had even more protection than vaccinated individuals who had not had COVID-19 before.

https://www.ox.ac.uk/news/2021-08-19-vaccines-still-effective-against-delta-variant-concern-says-oxford-led-study-covid-0

How the coronavirus infects cells — and why Delta is so dangerous

Scientists are unpicking the life cycle of SARS-CoV-2 and how the virus uses tricks to evade detection.

Photo by CDC on Unsplash

https://web.archive.org/web/20210731235001/https://www.nature.com/articles/d41586-021-02039-y

India’s vaccinations hit record with free COVID shots

India gave out a record 7.5 million vaccine doses on Monday under a federal campaign to inoculate all adults for free after weeks of criticism that a chaotic rollout had worsened a second wave that killed hundreds of thousands.

https://www.reuters.com/world/india/india-reports-53256-new-covid-19-cases-2021-06-21/

Novavax COVID-19 Vaccine Demonstrates 90% Overall Efficacy

Novavax, Inc. today announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial.

Photo by CDC on Unsplash

The study enrolled 29,960 participants across 119 sites in the U.S. and Mexico to evaluate efficacy, safety and immunogenicity, with an emphasis on recruiting a representative population of communities and demographic groups most impacted by the disease.

https://web.archive.org/web/20210614142329/https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-90-overall-efficacy-and

Health Canada authorizes use of the Pfizer-BioNTech COVID-19 vaccine in children 12 to 15 years of age

Today, Health Canada authorized the use of the Pfizer-BioNTech COVID-19 vaccine in children 12 to 15 years of age. This is the first COVID-19 vaccine authorized in Canada for use in children and marks a significant milestone in Canada's fight against the COVID-19 pandemic.

https://www.canada.ca/en/health-canada/news/2021/05/health-canada-authorizes-use-of-the-pfizer-biontech-covid-19-vaccine-in-children-12-to-15-years-of-age.html

Covid-19: Infections fell by 65% after first dose of AstraZeneca or Pfizer vaccine, data show

Infections of SARS-CoV-2 fell by 65% after a first dose of the Oxford-AstraZeneca or Pfizer-BioNTech vaccines, preliminary results from a large UK surveillance study indicate.

Reductions increased to 70% after a second dose of the Pfizer vaccine, data from the UK Covid-19 Infection Survey show. Not enough people had yet received two doses of the AstraZeneca vaccine to assess this.

https://www.bmj.com/content/373/bmj.n1068

Denmark continues vaccine rollout without the AstraZeneca vaccine

The National Board of Health paused the use of the COVID-19 vaccine from AstraZeneca on March 11, 2021. This was done on the basis of worrying signals from the ongoing safety monitoring of the COVID-19 vaccines. The vaccination program has since then continued with the vaccines from Pfizer / BioNTech and Moderna.

https://www.sst.dk/da/Nyheder/2021/Danmark-fortsaetter-vaccineudrulning-uden-AstraZeneca-vaccinen

Hard choices emerge as link between AstraZeneca vaccine and rare clotting disorder becomes clearer

What was a worrisome suspicion 4 weeks ago is now widely accepted: The AstraZeneca COVID-19 vaccine can, in very rare cases, cause a disorder characterized by dangerous blood clots and low platelet counts. In Europe, at least 222 suspected cases have been reported among 34 million people who have received their first dose of the vaccine. More than 30 have died.

https://www.science.org/content/article/hard-choices-emerge-link-between-astrazeneca-vaccine-and-rare-clotting-disorder-becomes

Bharat Biotech Announces Phase 3 Results of COVAXIN®: India’s First COVID-19 Vaccine Demonstrates Interim Clinical Efficacy of 81%

Bharat Biotech, a global leader in vaccine innovation, developing vaccines for infectious diseases, today announced the first interim analysis of its BBV152 (COVAXIN®). The whole virion inactivated COVID-19 vaccine candidate demonstrated an interim vaccine efficacy of 81% in its Phase 3 clinical trial. The trials involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research.

https://web.archive.org/web/20210303153432/https://www.bharatbiotech.com/images/press/covaxin-phase3-efficacy-results.pdf