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U.S. Gives Full Approval to Moderna’s COVID Vaccine
U.S. health regulators on Monday granted full approval to Moderna’s COVID-19 vaccine, a shot that’s already been given to tens of millions of Americans since its emergency authorization over a year ago.
The action by the Food and Drug Administration means the agency has completed the same rigorous, time-consuming review of Moderna’s shot as dozens of other long-established vaccines.
The decision was bolstered by real-world evidence from the more than 200 million doses administered in the U.S. since the FDA cleared the shot in December 2020. The FDA granted full approval of Pfizer’s vaccine last August.
Ivermectin Shows ‘Antiviral Effect’ Against COVID, Japanese Company Says
Japanese trading and pharmaceuticals company Kowa Co Ltd (7807.T) on Monday said that anti-parasite drug ivermectin showed an “antiviral effect” against Omicron and other coronavirus variants in joint non-clinical research.
The company, which has been working with Tokyo’s Kitasato University on testing the drug as a potential treatment for COVID-19, did not provide further details. Clinical trials are ongoing, but promotion of ivermectin as a COVID-19 treatment has generated controversy.
The use of ivermectin to treat COVID-19 is currently being investigated in a UK trial run by the University of Oxford. The researchers said on Monday that it was still under way and they did not want to comment further until they have results to report.
Dr. Fauci and the Coronavirus Policy Blame Game
With millions of Americans getting infected and over 800,000 reported COVID-19 deaths, most people now realize that Washington’s pandemic policies failed. Lockdowns just postponed the inevitable while causing enormous collateral damage on cancer, cardiovascular disease, diabetes, tuberculosis, mental health, education and much else.
So, the blame game is in full swing. At a recent Senate hearing, Dr. Anthony Fauci did not even attempt to defend his policies. Instead, he insisted that: “Everything that I have said has been in support of the CDC guidelines.”
Dr. Fauci, as director of the National Institute of Allergy and Infectious Diseases (NIAID), has worked closely with the two CDC directors, Drs. Robert Redfield and Rochelle Walensky, throughout the pandemic, but he is now laying the responsibility on them. He did the same with his former boss, shortly after Dr. Francis Collins resigned as director of the National Institutes of Health (NIH).
Novavax Asks FDA to Authorize Its COVID Vaccine
Novavax asked the Food and Drug Administration on Monday to authorize its protein-based COVID-19 vaccine for adults.
The vaccine is already available for use in at least 170 countries, but if cleared for emergency use in the U.S., it would provide an alternative to the popular mRNA-based shots from Pfizer and Moderna.
For certain groups of people — particularly young men — the mRNA vaccines carry a slightly elevated risk of a heart condition called myocarditis. Novavax’s vaccine has not been linked to myocarditis.
COVID Predictions? These Experts Are Done With Them
The emergence of the Omicron variant this fall, with an origin story that experts say remains shrouded in mystery, became the latest sharp turn for researchers trying to catch up with the virus and its variants.
Omicron, which has about 50 genetic mutations, developed outside of researchers’ view, with an evolutionary history far removed from the family tree of the once-dominant Delta. Instead, its roots are in an old version of the virus thought to have faded away months ago.
Scientists say they can outline scenarios for how the virus could evolve, but variants remain COVID’s unknowable wild card. In two years, they have rewritten the script so radically, many researchers are cautious to venture educated guesses of how COVID-19 will play out.
146 Research Studies Affirm Naturally Acquired Immunity to COVID
We should not force COVID vaccines on anyone when the evidence shows that naturally acquired immunity is equal to or more robust and superior to existing vaccines. Instead, we should respect the right of the bodily integrity of individuals to decide for themselves.
Public health officials and the medical establishment with the help of the politicized media are misleading the public with assertions that the COVID-19 shots provide greater protection than natural immunity.
Moreover, existing immunity should be assessed before any vaccination, via an accurate, dependable, and reliable antibody test (or T cell immunity test) or be based on documentation of prior infection (a previous positive PCR or antigen test). Such would be evidence of immunity that is equal to that of vaccination and the immunity should be provided the same societal status as any vaccine-induced immunity.
COVID May Have Seasons for Different Temperature Zones, Study Suggests
COVID-19 transmission may have seasonal spikes tied to temperature and humidity, increasing at different times of the year for different locations, a new study in the American Journal of Tropical Medicine and Hygiene suggests.
Colder regions, such as the U.S. Northeast, may experience more cases during winter, while warmer regions, such as the southern United States, may see higher transmissions in the summer. More-temperate zones could experience two seasonal peaks.
In California Nursing Homes, Omicron Is Bad, but so Is the Isolation
Dina Halperin had been cooped up alone for three weeks in her nursing home room after her two unvaccinated roommates were moved out at the onset of the Omicron surge. “I’m frustrated,” she said, “and so many of the nursing staff are burned out or just plain tired.”
Over time, the Victorian Post Acute facility in San Francisco has gotten better at dealing with the virus, especially its milder Omicron form, which accounted for 31 cases as of Jan. 27 but not a single illness serious enough to cause hospitalization, said Dan Kramer, a spokesperson for Victorian Post Acute.
But the ongoing safety protocols at this and other nursing homes — including visitor restrictions and frequent testing of staff and residents — can be soul-killing. For the 1.4 million residents of the nation’s roughly 15,000 nursing homes, the rules have led to renewed isolation and separation.
New York City to Deliver COVID Antiviral Pills to Eligible Residents Free of Charge, Adams Says
New York City is making progress in the fight against the Omicron variant, Mayor Eric Adams announced Sunday. Adams said indicators show cases are rapidly declining, and hospitalizations and deaths are down, too.
Mayor Adams said the city will deliver COVID antiviral pills to eligible New Yorkers same day, free of charge.
“Oral antiviral pills, like Paxlovid and Molnupiravir, taken for five days help stop the virus from reproducing, which reduces the amount of virus in the body and prevents symptoms from getting worse,” Health Commissioner Dr. Dave Chokshi added.
Britain to Offer COVID Vaccinations to Vulnerable Children Aged 5 to 11
Britain will this week begin offering vaccinations to children aged between five and 11 who are most at risk from coronavirus, the state-run National Health Service said on Sunday.
Britain has been slower than some other countries in offering the shots to 5 to 11 year olds, and is not planning to vaccinate the age group more broadly unlike countries such as the United States and Israel.
NHS England said children in the cohort who were in a clinical risk group or who live with someone who is immunosuppressed would be able to get a first COVID-19 shot, in line with advice issued last month by the Joint Committee on Vaccine and Immunisation (JCVI)
Clinics in Moscow Now Offering Sputnik M Vaccines to 12 to 17s
The Russian capital on Monday has started offering a domestically developed coronavirus vaccine to children in the 12 to 17 age group amid the country’s biggest infection surge yet due to the spread of the highly contagious Omicron variant.
Free shots of Sputnik M — a version of the Sputnik V vaccine that contains a smaller dose — became available last week to 12 to 17s in a number of Russian regions spanning from the region surrounding Moscow to the Urals to Siberia and the far east, with the capital being the latest addition to the list.
