Study finds Pfizer COVID-19 pill had no benefit in middle-age adults
Paxlovid, the COVID-19 antiviral pill developed by Pfizer that was once celebrated as a "game-changer" for the pandemic, has little to no benefit for younger adults, while it still appears to reduce the risk of hospitalization or death for high-risk seniors, according to a new study published Wednesday.
“Among patients 65 years of age or older, the rates of hospitalization and death due to Covid-19 were significantly lower among those who received nirmatrelvir than among those who did not,” the study published in the New England Journal of Medicine stated. "No evidence of benefit was found in younger adults."
\u201c#Paxlovid with zero benefit in those aged <65yo with #covid19 in new @NEJM retrospective case-control study of 109,254.\nYes, a statistical benefit in >65yo (which is the headline), but no NNT mentioned. Cost might be $1/2Mil to prevent 1 hospitalization.\n\nhttps://t.co/m9DyGpMRJg\u201d— David Boulware, MD MPH (@David Boulware, MD MPH) 1661381533
Israeli researchers examined data from 109,254 Omicron-variant coronavirus patients over the age of 40 who are members of Clalit Health Services, the largest of Israel's four state-mandated health service organizations. They found Paxlovid reduced hospitalizations of individuals 65 and older by about 75% when administered shortly after infection. Those results were consistent with clinical trials, which found the drug had an 89% reduction in the risk of hospitalization and death and prompted U.S. health authorities to grant Pfizer an emergency use authorization for the pill.
However, when it came to adults between 40 and 65, the drug was shown to have no measurable benefit, according to the analysis of patient data.
"Among patients 65 years of age or older, the rate of hospitalization due to Covid-19 was 14.7 cases per 100,000 person-days among treated patients as compared with 58.9 cases per 100,000 person-days among untreated patients," the study said.
"Among patients 40 to 64 years of age, the rate of hospitalization due to Covid-19 was 15.2 cases per 100,000 person-days among treated patients and 15.8 cases per 100,000 person-days among untreated patients."
The study authors acknowledged limitations in its design, which took a retrospective look at Israeli medical data rather than enrolling patients in a randomized study with a control group. They noted that some patients may not have had access to Paxlovid or that differences in early diagnosis could affect who was given the pill, which means some data on how individuals respond to treatment could be missing.
"We assume that the patients who were likely to be hospitalized because of severe symptoms were systematically treated at a higher rate. Since these symptoms were not reported consistently, it is likely that the treatment effect was underestimated in this study," the authors wrote.
The Biden administration has given a full-throated endorsement of Paxlovid to combat the pandemic, backed by more than $10 billion spent purchasing the drug and making it available to Americans.
The U.S. Food and Drug Administration granted emergency authorization for the drug late last year for adults and children 12 years or older who are considered to be at high risk because of pre-existing conditions like obesity, diabetes, and heart disease.
The Associated Press reported that more than 3.9 million prescriptions for Paxlovid have been filled since the drug was approved. President Joe Biden and White House chief medical adviser Dr. Anthony Fauci are among those who have been prescribed Paxlovid to treat their COVID-19 infections.
Doctors recommend that those given a Paxlovid prescription to treat their COVID-19 infection begin taking antiviral pills immediately. The recommended prescription is three pills taken twice a day for five days, according to Scripps Health.
Common side effects of Paxlovid include diarrhea, nausea, vomiting, and an altered sense of taste.
“Ironically, these can also be symptoms of COVID-19. The side effects of Paxlovid can sometimes outweigh the benefits of taking the medication, which is another reason why this medication is prescribed only to those at high risk,” according to Dr. Ghazala Sharieff, Scripps Health chief medical officer.
Health officials advise that certain common medications may have adverse interactions with Paxlovid and should avoid being taken during treatment with Paxlovid for COVID-19.
“There are certain medications, such as statins and other cholesterol-lowering drugs, where you need to consult with your physician regarding possible interactions,” Dr. Sharieff said. “But for some medications, like drugs that regulate heart rhythm, Paxlovid is not indicated. In those cases, your doctor may recommend another antiviral medication, such as molnupiravir or monoclonal antibody treatment, for COVID-19 instead.”
Some COVID-19 patients who take Paxlovid may experience a "rebound" case of COVID-19. Some studies have suggested that one in 10 coronavirus patients will experience a rebound after their initial symptoms have gone away and that use of Paxlovid was associated with greater incidence of viral rebound compared to no treatment.
NYC company, owned by family who donated $300K to Gov. Hochul, paid $637 million for at-home COVID tests — without a contract
A company owned by a family which has donated $300,000 to the re-election campaign for New York Governor Kathy Hochul has been paid $637 million by the state over the past eight months to manufacture at-home COVID tests, and the entire arrangement has gone on without either party ever signing a contract.
According to the Times Union, Digital Gadgets LLC, owned by New York City businessman Charlie Tebele, has manufactured approximately 52 million at-home COVID tests since late November and sold them to the state of New York for either $13 or $11.50 each. Though the price per test appears to be reasonable, the state did not consider any other bids from competing manufacturers.
Nor did it seal the specifics of their agreement with a contract. The office of the state comptroller Tom DiNapoli issued almost 240 separate payments to Digital Gadgets between December 30 and March 25, but those transactions have been considered individual "purchase orders." DiNapoli's spokesperson denied that his office ever reviewed or approved them.
He didn't have to. When Hochul declared a state of emergency last November to combat the omicron variant surge, some New York finance laws were suspended, including laws regarding competitive bidding and comptroller oversight of state contracts, as a result.
But members of the state Republican Party aren't buying that explanation.
“I’m calling on Governor Hochul, and the department of health, to turn over all of their communications with the Tebele family and Digital Gadgets,” said state Republican Party Chair Nick Langworthy. “New Yorkers need to know who our government spoke to and when they spoke to them, and what was discussed.”
Langworthy claimed that he will soon file a Freedom of Information Act request to uncover more particulars about the transactions between the governor's office and Digital Gadgets and that he will ask a U.S. attorney to investigate the issue as well.
Despite the appearance of impropriety, however, Hochul has denied doing anything untoward. Hochul said that the state received test samples from several companies but that Digital Gadgets was the only manufacturer which could produce the number of tests needed by January 2022.
“The fact that there was someone who could meet that need at the time allowed us to deliver critically important test kits when nobody else, including the federal government, could get their hands on them,” Hochul said. “As a result we got kids back in school in January as opposed to them sitting home another semester.”
She also denied knowing that the Tebeles had donated so generously to her campaign.
“I was not aware that this was a company that had been supportive of me,” Hochul said. “I don’t keep track of that.”
The executive order for the state of emergency has been extended until August 13, but it may be extended again if Gov. Hochul deems it necessary.
Pfizer vaccine's protection against Omicron drops as soon as three weeks after third dose: Study
The effectiveness of Pfizer and BioNTech's COVID-19 vaccine wanes rapidly against the Omicron variant, beginning to fade away as soon as three weeks after the second or third dose, a new study finds.
Researchers said that the antibody responses induced by a second and third dose of the vaccine were "transient" and that "additional booster doses may be necessary," although the vaccine still provides enough immunity to ward off hospitalization and death from COVID-19.
The Danish study, which was published in JAMA Network Open on Friday, examined 128 people who had received two or three doses of Pfizer/BioNTech's mRNA vaccine.
Scientists observed that the number of "neutralizing" antibodies induced by the vaccine that target the Omicron variant declined rapidly within weeks of taking the second and third shots. Antibodies attack the virus and stop it from replicating, which protects the body against infection and disease.
The study examined the antibody response in vaccinated patients to different strains of the coronavirus, including the original and Delta variant strains. Within four weeks of the second Pfizer/BioNTech dose, the concentration of Omicron-specific antibodies found in patients' blood was 14-fold lower than antibodies against the original virus strain.
Compared to the original and Delta variants, the proportion of Omicron-specific neutralizing antibodies fell "rapidly" from 76.2% four weeks after the second shot to 53.3% at weeks eight to 10, and then 19% at weeks 12 to 14, the researchers said.
After a third dose, Omicron-specific antibodies increased nearly 21-fold at week three and nearly 8-fold at week four, compared to antibody levels observed four weeks after the second dose.
However, antibody levels dropped between the third week and the eighth week after the third dose, with a 4.9-fold drop for the original strain, 5.6-fold for Delta, and 5.4 fold for Omicron observed.
This means that the number of antibodies the vaccine teaches the body to make to fight COVID-19 drops off as soon as four weeks after the second shot and three weeks after the third. Lower antibody levels offer less protection against the virus, which explains why people who have been fully vaccinated with two shots or have only had one booster may still get breakthrough Omicron infections.
The researchers say that additional booster shots may be needed to keep Omicron-specific antibody levels high and protect against disease, especially in older people.
Previous studies have shown that protection against infection offered by COVID-19 vaccines begins to wane after about six months. Older Americans, who are more vulnerable to severe disease, have been encouraged by public health officials to take vaccine booster shots to strengthen their antibody response to the virus.
According to U.S. Centers for Disease Control and Prevention data, about 69% of U.S. adults over age 65 have received a booster dose, while nearly 91% have completed their primary COVID-19 vaccination schedule.
The U.S. Food and Drug Administration in March authorized a second booster shot for Americans over the age of 50, citing evidence that suggested vaccine protection wanes over time and that older and immunocompromised people need additional protection offered by a fourth dose.
Shanghai begins phased lockdown as COVID surges in China's largest city
Shanghai has begun a phased COVID-19 lockdown, as China’s largest financial hub grapples with a massive surge in cases of the Omicron variant. China is currently seeing case numbers that it hasn’t experienced since the early days of the pandemic.
Parts of Shanghai on the eastern side of the Huangpu River — which divides the city roughly down the center — will be under lockdown between Monday and Friday, according to local officials.
Western parts of Shanghai will undergo a similar lockdown protocol starting on April 1.
The Guardian reported that Shanghai officials are also implementing massive testing protocols.
Shanghai, China’s largest city, consisting of 25 million people, has recently become the hot spot for a nationwide outbreak of COVID that began in early March.
Chinese President Xi Jinping, earlier this month, urged officials in the Chinese Communist Party to “minimize the impact” of the virus on the Chinese economy as authorities work to uphold the country’s extremely aggressive “zero-COVID policy.”
On Monday, the Chinese stock exchange opened lower than expected, with the country’s benchmark CSI 300 index — analogous to the DOW Jones Industrial Average — falling as much as 2% during morning trading hours.
The government ruled out shutting down Shanghai entirely on Saturday, citing the potential damage it could cause the Chinese economy, and opted instead to implement the phased east-west lockdown approach.
On Sunday, a record 3,450 asymptomatic cases were reported in Shanghai, which accounted for nearly 70% of the nationwide total. Shanghai city officials announced 50 symptomatic cases on Monday.
The Chinese National Health Commission announced on Monday that there were 5,134 new asymptomatic cases nationally, with 1,219 new infections confirmed to be from Shanghai.
Currently, in the eastern parts of Shanghai, residents are confined to their homes. The city directed health care workers to visit each residence and conduct rapid COVID tests, with some workers arriving as early as 7 a.m. Monday morning.
In a Sunday public notice, the Shanghai government said that the two-part lockdown was being implemented “to curb the spread of the epidemic, ensure the safety and health of the people” and root out cases of infection “as soon as possible.”
The city’s eastern half will be under lockdown until April 1, at which point its western half will undergo lockdown until April 5.
Residents are being compelled to stay indoors during these lockdowns, and all businesses, employees, and government personnel who are not involved in the supply of essential services are required to work from home.
Individuals who are responsible for providing vital services such as gas, electricity, transport, sanitation, and food delivery do not have to adhere to the stay-at-home order.
'They will not silence me': Doctor who raised alarm about Omicron says she was pressured by international politicians and scientists to not say it is 'mild'
The South African doctor who was one of the first people to raise the alarm about the Omicron variant claims she was pressured by politicians and scientists "not to publicly state that it was a mild illness," and to instead say the strain is "serious."
Dr. Angelique Coetzee — who serves as the chairwoman of the South African Medical Association — was one of the first to identify the Omicron variant.
In November 2021, Coetzee started seeing patients with "symptoms that did not make immediate sense," including "intense fatigue."
"It presents mild disease with symptoms being sore muscles and tiredness for a day or two not feeling well," Coetzee said in November. "So far, we have detected that those infected do not suffer loss of taste or smell. They might have a slight cough. There are no prominent symptoms. Of those infected some are currently being treated at home."
It turned out that Coetzee's patients were infected with SARS-CoV-2 — B.1.1.529, a strain more commonly known as the Omicron variant.
After Coetzee went public with her findings, she was allegedly inundated with demands to renounce her determination that the new COVID-19 strain was "mild."
"I was told not to publicly state that it was a mild illness," Coetzee told German newspaper Welt this week. "I have been asked to refrain from making such statements and to say that it is a serious illness. I declined."
However, Coetzee said, "Based on the clinical picture there are no indications that we are dealing with a very serious disease."
"The course is mostly mild," she continued. "I’m not saying you won’t get sick if you’re mild."
Coetzee — who has been a doctor for 33 years — referred to the World Health Organization's guidance for management of mild COVID-19:
Patients with mild disease do not require hospital interventions, but isolation is necessary to contain virus transmission and will depend on national strategy and resources. Provide patients with mild COVID-19 with symptomatic treatment such as antipyretics for fever. Counsel patients with mild COVID-19 about signs and symptoms of complicated disease. If they develop any of these symptoms, they should seek urgent care through national referral systems.
She continued, "A serious illness is one in which we see acute pulmonary respiratory infections: people need oxygen, maybe even artificial respiration. We saw that with Delta — but not with Omicron."
Coetzee vowed, "They will not silence me."
Coetzee also gave an interview to Australia's Daily Telegraph this week, where she reiterated that she was the target of "attacks" from international scientists and politicians.
"Because of all of Covid’s mutations, all of these scientists and politicians who aren’t from South Africa were contacting me telling me I was wrong when I spoke out, that it was a serious disease ... they were telling me I had no idea what I was talking about, they kept attacking me," Coetzee told the outlet.
"In South Africa it is a lighter disease, but in Europe it has been a serious, serious illness, which is what the politicians want me to say ... there has been a lot of pressure from European scientists and politicians who have said, 'Please don’t say it is a mild illness.'"
"They are accusing me of lying, of downplaying Omicron because of how it has been in Europe ... in their minds, it is impossible for a disease with more than 38 mutations to be mild," she explained.
"But I have stated many times before it can be a serious illness if you are unvaccinated and have comorbidities but for the majority of people it is a mild illness. I am the one who has seen the patients first-hand but the politicians won’t listen."
Coetzee notes that if clinical research proves her wrong, then she will apologize.
But until that happens, she will "stick to her guns."
"I will not give in to pressure and I am not easily intimidated," she stated.
In both interviews, she did not reveal exactly which "scientists and politicians" attempted to get her to walk back her Omicron remarks. But she did say she was put under pressure from scientists from the U.K. and the Netherlands.
More than 300,000 jobs lost in January thanks to Omicron, ADP says
Although President Joe Biden promised to shut down the coronavirus, it seems the virus is shutting down job growth, as disappointing numbers reported Wednesday reveal.
Private-sector employment decreased by 301,000 jobs from December to January, according to a report from the payroll processing firm ADP. It's an unexpected blow for the Biden economy after Dow Jones estimated jobs would grow by 200,000 in January, following a revised 776,000 jobs gained in December. It was the first month of negative job growth reported since December 2020.
ADP's chief economist attributed the job losses to the spread of the Omicron variant of coronavirus.
"The labor market recovery took a step back at the start of 2022 due to the effect of the Omicron variant and its significant, though likely temporary, impact to job growth," Nela Richardson, chief economist for ADP, said. "The majority of industry sectors experienced job loss, marking the most recent decline since December 2020. Leisure and hospitality saw the largest setback after substantial gains in fourth quarter 2021, while small businesses were hit hardest by losses, erasing most of the job gains made in December 2021."
More than half of the job losses happened in the leisure and hospitality industries, where companies reported a loss of 154,000 jobs. Trade, transportation, and utilities firms reported 62,000 jobs lost, while health care and social assistance categories lost 10,000.
There were 21,000 manufacturing jobs lost, and 10,000 construction jobs are gone.
In total, industries that provide services lost 274,000 jobs, while jobs in industries that produce goods fell by 27,000.
Small businesses were hit hardest. Firms with fewer than 50 employees were responsible for 144,000 jobs lost, with 106,000 of those jobs coming from businesses with fewer than 20 employees.
Medium-sized businesses with between 50 and 499 employees lost 59,000 jobs. Large businesses with more than 500 employees lost 98,000.
Later this week, the U.S. Labor Department will release its January jobs report, a more closely watched jobs figure that is expected to show the economy added 150,000 jobs last month. Even if the government reports jobs growth close to that estimate, it's a substantial decrease from the number of jobs gained in December.
White House press secretary Jen Psaki told reporters on Tuesday to expect a negative number.
"Because Omicron was so highly transmissible, nearly 9 million people called out sick in early January when the jobs data was being collected," Psaki said. "The week the survey was taken was at the height of the Omicron spike ... As a result, the jobs report may show job losses, in large part because workers were out sick from Omicron at a point when it was peaking."
Hourly employees who called in sick with COVID-19 and stayed home without paid leave are not counted as employed, even though they have not been laid off. The Labor Department's jobs survey took place between Jan. 9 and 15, during a peak of COVID-19 cases.
Test tube study shows ivermectin has 'antiviral effect' against Omicron, Japanese company says
A Japanese pharmaceutical company on Monday reported that ivermectin, a drug used to fight parasites, showed an "antiviral effect" against Omicron and other coronavirus variants in a study.
Kowa Company, Ltd. partnered with Tokyo's Kitasato University in a joint laboratory study that looked at ivermectin as a potential treatment for COVID-19, Reuters reports. The company said in a press release that clinical trials for the study are ongoing.
The use of ivermectin to treat COVID-19 is highly controversial. A June 2020 study found that the drug appeared to have an antiviral effect against COVID-19 in vitro, colloquially meaning "test tube experiments." Those early promising results spurred hope that ivermectin could be developed into an effective treatment for COVID-19, but clinical studies with real-life patients considered by the U.S. government did not demonstrate the drug was effective at treating COVID-19.
Lots of stuff has a antiviral effect in a test tube but doesn't help fight viral disease in humans, so while it was disappointing that Ivermectin doesn't help with Covid, it wasn't very surprising.— Arieh Kovler (@Arieh Kovler) 1643644373
An investigative report by the BBC found that more than a third of 26 major trials with ivermectin against COVID-19 had "serious errors or signs of potential fraud" and that the remaining studies did not show it was effective as a treatment for COVID.
Kowa's press release confirms that ivermectin has the same antiviral effect against the Omicron variant in test tube experiments as it previously had with other variants of the virus.
MORE - Kowa's press release on ivermectin in full for reference. The English version is auto-translated.\n\nhttps://www.kowa.co.jp/news/2022/press220131.pdf\u00a0\u2026pic.twitter.com/q7qHecPDwz— Disclose.tv (@Disclose.tv) 1643636025
Ivermectin is not approved for use against COVID-19 in Japan and the U.S. Food and Drug Administration has repeatedly warned against its use as a COVID-19 therapeutic. The World Health Organization, the EU drug regulator, and Merck, the manufacturer of ivermectin, have also warned against its use.
Still, some doctors in the U.S. and medical freedom advocates have petitioned for a right to try ivermectin and other unproven COVID-19 therapeutics because of claims that some coronavirus patients have shown improvement after taking the drug.
When popular podcast host Joe Rogan came down with COVID last fall, he announced that he took "all kinds of meds" to treat his illness, including ivermectin and monoclonal antibodies. After he recovered, Rogan was derided by the media and falsely accused of taking a "horse dewormer."
While there is an ivermectin paste available as an anti-parasitic treatment for animals, there is also a version of the medication made for human beings, and that's the medicine Rogan took. The paste version is not intended for human consumption and could be dangerous if overdosed.
The in vitro findings of the Kowa Company's study will need to be supported by clinical studies that show vermectin is effective against COVID-19 before public health authorities will acknowledge the drug as a potential therapeutic for coronavirus.
Serial hypocrite Gavin Newsom pictured without mask at NFC Championship game
California Gov. Gavin Newsom and Los Angeles Mayor Eric Garcetti flouted COVID-19 rules at the NFC Championship Game at SoFi Stadium Sunday, where the Rams defeated the 49ers to advance to the Super Bowl.
Magic Johnson took photos with each of the California Democrats in a suite at the game and later posted them on his Instagram page. Johnson also posted a picture with a maskless San Francisco Mayor London Breed.
In flagrant violation of Los Angeles County's COVID-19 restrictions and the rules at SoFi Stadium, Newsom was pictured with Johnson and neither of them was wearing a face mask. So was Garcetti, in another photo.
The rules to attend the game were perfectly clear. Every guest above the age of 5 was required to present proof of "full vaccination" or a negative COVID-19 test result to gain entry to the stadium.
"Masks are required for all attendees except when actively eating or drinking," a notice from the stadium said, in accordance with an order from the Los Angeles County Department of Pubic Health.
The pictures of Newsom and Garcetti breaking the rules seemingly without consequence provoked a response from California state Sen. Melissa Melendez (R).
"Toddlers are being forced to wear masks all day long in school. Maybe one day they'll be governor or the mayor of L.A. and they won't have to follow the rules they impose on others," Melendez tweeted.
Toddlers are being forced to wear masks all day long in school. Maybe one day they\u2019ll be governor or the mayor of LA and they won\u2019t have the follow the rules they impose on others.pic.twitter.com/YGJDZeBxGA— Senator Melissa Melendez (@Senator Melissa Melendez) 1643604049
L.A.-based sports agent Fadde Mikhail, a Republican candidate for Congress, was also at the game and said he was sitting near Newsom and did not see him wear a mask at all during the game.
"IF our governor doesn’t wear a mask in a stadium with 80K in it, why the hell should anyone be wearing a mask," Mikhail said.
FYI\u2026I was two boxes down from Gov. @GavinNewsom . Not once, was he wearing a mask. IF our governor doesn\u2019t wear a mask in a stadium with 80K in it, why the hell should anyone be wearing a mask. #CA26 #ImRunning for you.— Fadde (@Fadde) 1643601957
"If @GavinNewsom can attend an indoor mega-event MASKLESS with tens of thousands of other maskless fans, then so can our kids at school, especially when playing at recess," Jonathan Zachreson, a candidate for California state assembly, said.
In another photo, Garcetti was pictured standing on the field with the Rams mascot, and he was not wearing a mask.
Go #Rams!\n\n@RampageNFL and I are ready to see the Rams win Super Bowl LVI right back here in two weeks!pic.twitter.com/IOJuM65GVv— MayorOfLA (@MayorOfLA) 1643601196
Newsom is a serial hypocrite when it comes to coronavirus restrictions. In November 2020, the governor was pictured eating out at a California restaurant in the middle of a statewide lockdown. Nearly a year later in October 2021, shortly after imposing a vaccine mandate for children age 12 and up to attend schools in California, the governor admitted that his own 12-year-old daughter was not yet vaccinated.
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