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

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

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

FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine

Johnson & Johnson Single-Shot COVID-19 Vaccine Candidate Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee

Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend Emergency Use Authorization (EUA) for the Company’s single-shot COVID-19 vaccine candidate for adults 18 and older, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. The vote was based on a totality of scientific evidence provided by the Company, including efficacy and safety data from the Phase 3 ENSEMBLE trial.

https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-candidate-unanimously-recommended-for-emergency-use-authorization-by-u-s-fda-advisory-committee

Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial

Novavax, Inc. today announced that NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3%, in its Phase 3 clinical trial conducted in the United Kingdom (UK).

Photo by CDC on Unsplash

https://web.archive.org/web/20210128212457/https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-893-efficacy-uk-phase-3

India starts world’s largest COVID-19 vaccination drive

India started inoculating health workers Saturday in what is likely the world’s largest COVID-19 vaccination campaign, joining the ranks of wealthier nations where the effort is already well underway.

https://apnews.com/article/health-india-immunizations-coronavirus-pandemic-ab830864393480ea6dcc67b0571fc29c

India approves Oxford/AstraZeneca vaccine for emergency use in major breakthrough for Covid fightback

India has given a green light for emergency use of the Oxford-AstraZeneca vaccine, making it the first jab to be granted approval by regulators in the Covid-19 pandemic’s second worst-hit country.

https://www.independent.co.uk/news/world/asia/india-covid-vaccine-oxford-astrazeneca-b1781201.html

Oxford University/AstraZeneca vaccine authorised by UK medicines regulator

The government has today accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to authorise Oxford University/AstraZeneca’s COVID-19 vaccine for use.

https://www.gov.uk/government/news/oxford-universityastrazeneca-vaccine-authorised-by-uk-medicines-regulator

More than 137,000 people in UK receive first dose of COVID vaccine in one week

More than 137,000 people in the UK have received the first dose of the Pfizer/BioNTech COVID-19 vaccine in the first week of the largest vaccination programme in British history.

https://www.gov.uk/government/news/more-than-137000-people-in-uk-receive-first-dose-of-covid-vaccine-in-one-week