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Omicron Boosters Are Weaker Against BQ.1.1 Subvariant That Is Rising in U.S., Study Finds
COVID shots designed to protect against the Omicron variant trigger a weaker immune response against the rapidly emerging BQ.1.1 subvariant than the previously dominant strain, according to a new lab study. Scientists at the University of Texas Medical Branch, in a study published online Tuesday in Nature Medicine, found that the booster shots performed well against the BA.5 subvariant they were designed to target.
But the boosters did not trigger a robust response when faced with BQ.1.1, the scientists found. Antibodies were about four times lower against BQ.1.1 compared with BA.5. These neutralizing antibodies prevent the virus that causes COVID-19 from invading human cells.
People with a prior history of infection who received an Omicron booster, however, had a stronger response to BQ.1.1. Antibodies that neutralize BQ.1.1 were nearly four times higher in this group compared with individuals with no history of infection who faced the subvariant, the scientists found.
Omicron BQ.1.1 subvariant appears on track to become the dominant variant in the U.S. It currently makes up about 32% of infections in the U.S., according to CDC surveillance data. Omicron BA.5, on the other hand, now represents about 14% of new infections.
Paxlovid Has Been Free So Far. Next Year, Sticker Shock Awaits.
Nearly 6 million Americans have taken Paxlovid for free, courtesy of the federal government. The Pfizer pill has helped prevent many people infected with COVID-19 from being hospitalized or dying, and it may even reduce the risk of developing long COVID. But the government plans to stop footing the bill within months, and millions of people who are at the highest risk of severe illness and are least able to afford the drug — the uninsured and seniors — may have to pay the full price.
Soon the Department of Health and Human Services will stop supplying COVID treatments, and pharmacies will purchase and bill for them the same way they do for antibiotic pills or asthma inhalers. Paxlovid is expected to hit the private market in mid-2023, according to HHS plans shared in an October meeting with state health officials and clinicians. Merck’s Lagevrio, a less-effective COVID treatment pill, and AstraZeneca’s Evusheld, a preventive therapy for the immunocompromised, are on track to be commercialized sooner, sometime in the winter.
The U.S. government has so far purchased 20 million courses of Paxlovid, priced at about $530 each, a discount for buying in bulk that Pfizer CEO Albert Bourla called “really very attractive” to the federal government in a July earnings call. The drug will cost far more on the private market, although in a statement to KHN, Pfizer declined to share the planned price. The government will also stop paying for the company’s COVID vaccine next year — those shots will quadruple in price, from the discount rate the government pays of $30 to about $120.
Bourla told investors in November that he expects the move will make Paxlovid and its COVID vaccine “a multibillion-dollar franchise.”
FDA ‘Turned a Blind Eye’ to ‘Submission of Fraudulent Data’ on COVID Vaccine, Says Former Criminal Investigator
On Nov. 2, 2021, The BMJ broke the story of Brook Jackson, the regional director who blew the whistle on data integrity issues in Pfizer’s pivotal COVID-19 vaccine trial. Weeks later, documents were leaked supporting Jackson’s complaint about “falsified data.”
Among the leaked documents was an email, authored by a former federal agent in the FDA’s Office of Criminal Investigations (OCI), claiming Pfizer knowingly submitted fraudulent data to the FDA, and the agency responded by turning a blind eye.
OCI is the FDA’s criminal law enforcement arm. Much like a police force, it conducts criminal investigations of illegal activities involving FDA-regulated products and brings them before the Department of Justice for prosecution.
“Having worked at FDA, I see it as surprising, for many reasons, that the agency turned a blind eye to a company’s knowing submission of fraudulent data,” wrote the OCI officer, whose identity is suppressed after signing a non-disclosure agreement.
Pfizer Partners With Clear Creek Bio to Develop Oral COVID Drug
Pfizer Inc. (PFE.N) and Clear Creek Bio Inc. on Tuesday announced a collaboration to identify a potential drug candidate and develop a new class of oral treatment against COVID-19, as Pfizer seeks to expand its anti-infective pipeline.
Charlotte Allerton, Pfizer’s chief scientific officer, said COVID-19 has “the potential to remain a global health concern for years to come.” Pfizer already has a COVID antiviral pill Paxlovid, which the drugmaker expects to generate about $22 billion in revenue this year.
Pfizer has been making various deals to boost its portfolio. This year, it has announced acquisitions of Biohaven Pharmaceutical Holding Co (BHVN.N) and Global Blood Therapeutics for $11.6 billion and $5.4 billion, respectively, and also launched a company with Roivant Sciences (ROIV.O) focused on an experimental bowel disease treatment.
Under the agreement with Clear Creek Bio, the pharmaceutical giant will pay an undisclosed amount upfront as well as make additional milestone payments along with royalties on future product sales.
Rep. Louie Gohmert Urges HHS to Establish Vaccine Injury Table
As he prepares to depart Congress, Rep. Louie Gohmert (R-Texas) urges Health and Human Services (HHS) to establish a Vaccine Injury Table, as required by law.
In a statement issued exclusively to The Epoch Times, Gohmert said: “It is asinine that despite the fact that our government and pharmaceutical companies fast-tracked the production of an experimental vaccine and forced millions of Americans to take it or risk losing their jobs or freedom, that a vaccine injury table disclosing known side effects of the vaccine as required by law has yet to be developed for the COVID-19 shot.”
According to U.S. Code 247d-6e (5)(A): “The Secretary shall by regulation establish a table identifying covered injuries that shall be presumed to be directly caused by the administration or use of a covered countermeasure and the time period in which the first symptom or manifestation of onset of each such adverse effect must manifest in order for such presumption to apply.”
Even when someone suffers a side effect known to be caused by the vaccine, Gohmert said “the government is making it as difficult as possible to be compensated for the damages.”
Some COVID Clinical Trials Lacked Diversity, Female Representation
Women were underrepresented in pandemic trials of antiviral treatments, and sponsors didn’t recruit enough Black and Asian participants for human studies on COVID vaccines, a new JAMA analysis of more than 100 trials found.
Why it matters: Treatment regimens that are found to be effective in clinical trials can’t be confidently applied to all populations when certain groups are not adequately represented, researchers said.
What they found: The researchers analyzed 122 clinical trial studies that included more than 176,000 participants conducted during the pandemic from October 2019 to February 2022.
FDA Expected to Decide on Pfizer RSV Vaccine for Older Adults by May 2023
The Food and Drug Administration is expected to decide by spring whether to approve Pfizer’s vaccine to prevent respiratory syncytial virus or RSV, in adults ages 60 and older.
Pfizer, in a statement Wednesday, said the FDA has accepted its RSV vaccine candidate for review under an expedited process that reduces the approval process by four months. The FDA is expected to make a final decision on whether to approve the vaccine by May 2023.
The U.S. is facing an unusually tough RSV season this year. RSV transmission was very low during the COVID pandemic due to masking and social distancing measures. Many people did not get infected as a consequence, so population immunity is lower right now.
Pfizer is also developing a maternal vaccine to protect newborns who are too young for vaccination.
Novavax to Make COVID Vaccine Shots in Canada
Novavax Inc. (NVAX.O) said on Wednesday it will manufacture its COVID-19 vaccine in Canada after the country’s health regulator allowed its use in children aged between 12 and 17 years as a primary series of shots. Production of test batches of the protein-based vaccine, Nuvaxovid, will begin at the Montreal manufacturing center by early 2023, the company said.
The agency’s approval was based on a late-stage study that showed the vaccine was effective against COVID-19 in children aged between 12 and 17 years.
Hurt by a global supply glut in COVID-19 vaccine and waning demand, Novavax cut its full-year revenue forecast last month to a range of $2 billion and $2.3 billion. Shots from rivals Pfizer/BioNtech and Moderna were approved last year for the initial vaccination of adolescents in Canada, hurting the vaccine maker further.
Millions of Unused COVID Vaccines Will Expire at End of Year: Auditor General
Tens of millions of doses of COVID-19 vaccines are likely about to expire and go to waste because of a failure to manage an oversupply, Canada’s auditor general reported Tuesday — a failure with an estimated price tag of about $1 billion.
The government knew that by signing advanced purchase agreements with a number of pharmaceutical companies there was a risk of buying up more COVID-19 vaccines than Canadians needed.
Scientists Finally Know Why People Get More Colds and Flu in Winter
A chill is in the air, and you all know what that means — it’s time for cold and flu season, when it seems everyone you know is suddenly sneezing, sniffling or worse. It’s almost as if those pesky cold and flu germs whirl in with the first blast of winter weather.
Yet germs are present year-round — just think back to your last summer cold. So why do people get more colds, flu and now COVID-19 when it’s chilly outside?
In what researchers are calling a scientific breakthrough, scientists behind a new study may have found the biological reason we get more respiratory illnesses in winter. It turns out that the cold air itself damages the immune response occurring in the nose.
In fact, reducing the temperature inside the nose by as little as 9 degrees Fahrenheit (5 degrees Celsius) kills nearly 50% of the billions of virus and bacteria-fighting cells in the nostrils, according to the study published Tuesday in The Journal of Allergy and Clinical Immunology.
China Medical Expert Says COVID Has Mutated, Should Be Renamed — State Media
China should change its official name for COVID-19 to reflect the virus’ mutation, and patients with light symptoms should be allowed to quarantine at home, a leading authority on traditional Chinese medicine was quoted as saying on Wednesday.
Gu Xiaohong told the state-run Beijing Daily newspaper that the coronavirus’ Chinese name, which identifies it as a pneumonia-causing disease, should be changed to call it simply an infectious virus.
China’s approach to COVID — which has emphasized widespread testing and the quarantining of positive cases in specialized facilities — should change from “passive detection” to “active prevention”, with recuperation at home for light cases.
Gu said the China Association of Chinese Medicine’s infectious disease arm, which she heads, had reached a consensus to change how they describe the virus.
