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Tag Archives: Pfizers
CDC identifies possible safety issue with Pfizer’s updated Covid-19 vaccine but says people should still get boosted
CNN
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The US Centers for Disease Control and Prevention said Friday that there is a possible safety issue with the bivalent Covid-19 vaccine made by Pfizer and BioNTech but that it is unlikely to represent a true risk. The agency said it continues to recommend that people stay up-to-date with Covid-19 vaccines.
The CDC said one of its vaccine safety monitoring systems – a “near real-time surveillance system” called the Vaccine Safety Datalink – detected a possible increase in a certain kind of stroke in people 65 and older who recently got one of Pfizer’s updated booster shots.
A rapid response analysis of that signal revealed that seniors who got an bivalent booster might be more likely to have ischemic strokes within the first three weeks after their shots, compared with weeks four through six.
Ischemic strokes, the most common form, are blockages of blood to the brain. They’re usually caused by clots.
The Vaccine Safety Datalink, or VSD, is a network of large health systems across the nation that provides data about the safety and efficacy of vaccines through patients’ electronic health records. The CDC said it had identified possible confounding factors in the data coming from the VSD that may be biasing the data and need further investigation.
Of about 550,000 seniors who got Pfizer bivalent boosters and were tracked by the VSD, 130 had strokes in the three weeks after the shot, according to a CDC official who spoke to CNN on condition of anonymity because they weren’t authorized to share the data. None of the 130 people died.
The number of strokes detected is relatively small, said Dr. William Schaffner, an infectious disease expert at Vanderbilt University and a member of the CDC Advisory Committee on Immunization Practices’ Covid-19 Vaccine Work Group.
“These strokes are not a confirmed adverse event at the moment,” he said. “It’s like a radar system. You’re getting a blip on the radar, and you have to do further investigation to discover whether that airplane is friend or foe.”
The same safety signal has not been detected with the bivalent Moderna booster, the CDC said in its notice.
The agency noted that it has looked for and failed to find the same increase in strokes in other large collections of medical records, including those maintained by Medicare, the US Department of Veterans Affairs, as well as its Vaccine Adverse Event Reporting System, known as VAERS.
Neither Pfizer nor other countries that are using the vaccine have seen any increase in this kind of stroke, the agency said, and the signal was not detected in any other databases.
The CDC says that it does not recommend any change to vaccination practices at this time and that the risks of Covid-19 for older adults continue to outweigh any possible safety issues with the vaccine.
“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal,” the notice says.
“CDC and FDA will continue to evaluate additional data from these and other vaccine safety systems. These data and additional analyses will be discussed at the upcoming January 26 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.”
Pfizer said in a statement Friday, “Neither Pfizer and BioNTech nor the CDC or the U.S. Food and Drug Administration (FDA) have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines.
“Compared to published incidence rates of ischemic stroke in this older population, the companies to date have observed a lower number of reported ischemic strokes following the vaccination with the Omicron BA.4/BA.5-adapted bivalent vaccine.”
The bivalent boosters from Pfizer/BioNTech and Moderna protect against the original strain of the coronavirus as well as the Omicron BA.4 and BA.5 subvariants. Only about 50 million Americans ages 5 and up have gotten them since they were authorized last fall, according to CDC data.
Schaffner said he was part of a briefing Thursday with members of the Covid-19 Vaccine Work Group. He couldn’t share specific details about the briefing but said the safety signal was discussed.
His biggest takeaway was that the safety surveillance system is working.
It’s very likely that this is a false signal, he said, but it’s being investigated, which is important.
“You want a surveillance system that occasionally sends up false signals. If you don’t get any signals, you’re worried that you’re missing stuff.”
Schaffner said he would absolutely tell people to get their Covid-19 booster if they haven’t done so yet – even those 65 and older.
“Undoubtedly, the risk of a whole series of adverse events, including hospitalization, is much, much greater with Covid-19 than it is from the vaccine,” he said.
He also said the signal – if real – may be more a factor of numbers than an indication that one manufacturer’s vaccine is riskier than the other.
Nearly two-thirds of the people in the US who’ve gotten an updated booster – 32 million – have gotten Pfizer, compared with about 18 million Moderna shots.
Pfizer’s COVID-19 Vaccine Linked to Blood Clotting: FDA
Pfizer’s COVID-19 vaccine has been linked to blood clotting in older individuals, according to the U.S. Food and Drug Administration (FDA).
FDA researchers, crunching data from a database of elderly persons in the United States, found that pulmonary embolism—blood clotting in the lungs—met the initial threshold for a statistical signal and continued meeting the criteria after a more in-depth evaluation.
Three other outcomes of interest—a lack of oxygen to the heart, a blood platelet disorder called immune thrombocytopenia, and another type of clotting called intravascular coagulation—initially raised red flags, researchers said. More in-depth evaluations, such as comparisons with populations who received influenza vaccines, showed those three as no longer meeting the statistical threshold for a signal.
Researchers looked at data covering 17.4 million elderly Americans who received a total of 34.6 million vaccine doses between Dec. 10, 2020, and Jan. 16, 2022.
The study was published by the journal Vaccine on Dec. 1.
The FDA said it was not taking any action on the results because they do not prove the vaccines cause any of the four outcomes, and because the findings “are still under investigation and require more robust study.”
Dr. Peter McCullough, chief medical adviser for the Truth for Health Foundation, told The Epoch Times via email that the new paper “corroborates the concerns of doctors that the large uptick in blood clots, progression of atherosclerotic heart disease, and blood disorders is independently associated with COVID-19 vaccination.”
Pfizer did not respond to a request for comment.
How the Research Was Done
FDA researchers, with assistance from researchers with the Centers for Medicare & Medicaid Services (CMS), analyzed data from the CMS database. They included Medicare Fee-for-Service beneficiaries aged 65 or older who received a vaccine within the timeframe, were enrolled when they were vaccinated, and were enrolled for a “clean window” of time prior to vaccination. The window was 183 days or 365 days, depending on the outcome.
About 25 million people receive the Medicare Fee-for-Service, but only about 17 million were vaccinated during the period of time studied.
Researchers used probability testing to detect an increased risk of one or more of 14 outcomes following vaccination. The goal was to see whether vaccination may increase the risk of adverse outcomes, such as pulmonary embolism, or blood clotting in the lungs. If an outcome met a certain statistical threshold, that meant it could increase the risk.
The initial results of the safety monitoring detected an increased risk of four events, the FDA announced on July 12, 2021. They were the same four outlined in the new paper, which is the first update the agency has given on the matter since its announcement.
As of Jan. 15, 2022, 9,065 cases of a lack of oxygen to the heart—known as acute myocardial infarction—were detected, researchers revealed in the new study. As of the same date, 6,346 cases of pulmonary embolism, 1,064 cases of immune thrombocytopenia, and 263 cases of the coagulation were detected.
The primary analysis showed a safety signal for all four outcomes. Researchers tried adjusting the numbers by using different variables. For instance, at one point they adjusted for the variation of background rates, or the rates of each outcome in the general population prior to the pandemic. After certain adjustments—not all—the myocardial infarction, immune thrombocytopenia, and intravascular coagulation ceased being statistically significant.
Pulmonary embolism, though, continued to be statistically significant, the researchers said. Pulmonary embolism is a serious condition that can lead to death.
Limitations of the study included possible false signals and possible missed signals due to factors such as parameters being specified wrongly.
The conditions that didn’t trigger a signal included stroke, heart inflammation, and appendicitis.
The signals were detected only after Pfizer vaccination. Analyses for signals after receipt of the Moderna and Johnson & Johnson vaccines did not show any concerns.
Moderna and Johnson & Johnson did not respond to requests for comment.
Side Effects
All three vaccines have been linked to a number of side effects. Heart inflammation is causally linked to the Moderna and Pfizer shots, experts around the world have confirmed, while Johnson & Johnson’s has been associated with blood clots.
Other conditions, such as pulmonary embolism, have been reported to authorities and described in studies, though some papers have found no increase in risk following vaccination.
Approximately 4,214 reports of post-vaccination pulmonary embolism, including 1,886 reports following receipt of Pfizer’s vaccine, have been reported to the U.S. Vaccine Adverse Event Reporting System as of Dec. 9.
As of the same date, 1,434 reports of post-vaccination myocardial infarction, including 736 following receipt of Pfizer’s vaccine; 469 reports of post-vaccination immune thrombocytopenia, including 234 following receipt of Pfizer’s vaccine; and 78 reports of post-vaccination intravascular coagulation, including 42 after receipt of Pfizer’s vaccine, have been reported.
Reports to the system can be made by anybody, but most are lodged by health care workers, studies show. The number of reports are an undercount, according to studies.
The new study states that the FDA “strongly believes the potential benefits of COVID-19 vaccination outweigh the potential risks of COVID-19 infection.” No evidence was cited in support of the belief.
The FDA is set to meet with its vaccine advisory panel in January 2023 about the future of COVID-19 vaccines, as the vaccines have been performing much worse against Omicron and its subvariants.
McCullough told The Epoch Times: “A shortcoming of the CMS surveillance system is that it did not capture prior and subsequent SARS-CoV-2 infection which accentuate the cumulative risk of COVID-19 vaccination. Given the large number of individuals who have been vaccinated, the population attributable fraction of medical problems ascribed to the vaccines is enormous. I have concerns over the future burden to the healthcare system as a consequence of mass indiscriminate COVID-19 vaccination.”
Zachary Stieber is a senior reporter for The Epoch Times based in Maryland. He covers U.S. and world news.
Pfizer’s CEO rapped by regulator for making ‘misleading’ statements about children’s vaccines
Pfizer’s CEO has been rapped by the UK’s pharmaceutical watchdog for making “misleading” statements about children’s vaccines, The Telegraph can disclose.
Dr Albert Bourla used an interview with the BBC last December to claim that “there is no doubt in my mind that the benefits, completely, are in favour of” vaccinating youngsters aged five to 11 against Covid-19.
He argued that “Covid in schools is thriving” adding: “This is disturbing, significantly, the educational system, and there are kids that will have severe symptoms.”
The interview was published on Dec 2 – before the vaccine had been approved by Britain’s medical regulator for this age group.
Shortly after the article’s publication, a complaint was submitted to the pharmaceutical watchdog – the Prescription Medicines Code of Practice Authority (PMCPA) – by UsForThem, a parent campaign group which was set up to promote the plight of children during the pandemic.
‘Extremely promotional in nature’
The complaint alleged that Dr Bourla’s remarks about the children’s vaccine were “disgracefully misleading” and “extremely promotional in nature”, arguing that it breached several clauses of the Association of the British Pharmaceutical Industry’s (ABPI) code of practice.
“There is simply no evidence that healthy schoolchildren in the UK are at significant risk from the SARS COV-2 virus and to imply that they are is disgracefully misleading,” they said.
In September 2021, the Joint Committee on Vaccination and Immunisation (JCVI), had advised against a mass roll-out for children aged 12-15, saying the “margin of benefit” was “considered too small” and citing the low risk to healthy children from the virus.
But less than a fortnight later, ministers gave the green light for youngsters to be given a single dose of the Pfizer-BioNTech jab with the UK’s chief medical officers arguing that this would help to keep schools open.
It was not until February 2022 that the JCVI ruled that children aged 5-11 could be offered the vaccine – but ministers said the decision should be left up to parents.
A code of practice panel, convened by the PMCPA, found that Pfizer had breached the code in a number of different ways, including by misleading the public, making unsubstantiated claims, and by failing to present information in a factual and balanced way.
‘Up-to-date scientific evidence’
Pfizer appealed against the findings, strongly refuting UsForThem’s claims that Dr Bourla had breached the code of practice. They argued that his remarks were based on “up-to-date scientific evidence” and could be substantiated by the “publicly available independent benefit-risk assessments”.
Earlier in November an appeal board met to consider their arguments. The breaches of the code relating to misleading the public, making unsubstantiated claims and the lack of balance were upheld.
Why Pfizer’s RSV vaccine success is a big deal, decades in the making
Enlarge / An intensive care nurse cares for a patient suffering from respiratory syncytial virus (RSV), who is being ventilated in the children’s intensive care unit of the Olga Hospital of the Stuttgart Clinic in Germany.
As an unusually large and early seasonal surge of RSV cases inundate children’s hospitals around the country, pharmaceutical giant Pfizer offered a glimmer of hope Tuesday in the form of top-line, phase three clinical trial results.
The company’s experimental RSV vaccine—given to pregnant trial participants—was 82 percent effective at preventing severe RSV-related lower respiratory tract illness in the first three months of an infant’s life. It was 69 percent effective over the first six months, Pfizer announced.
“We are thrilled by these data as this is the first-ever investigational vaccine shown to help protect newborns against severe RSV-related respiratory illness immediately at birth,” Pfizer Chief Scientific Officer Annaliesa Anderson said in a statement.
The company said it planned to file for regulatory approval from the Food and Drug Administration by the end of the year, which may mean a vaccine could be available in time for next year’s RSV season.
The announcement is promising, but there are reasons for caution, too. The company has only released top-line results in a press release, for one thing. The data will have to go through more detailed outside review. Pfizer also noted that the vaccine failed to meet the second of the trial’s two primary goals, which was to reach the pre-determined statistical criteria for efficacy against non-severe RSV-related lower respiratory tract illness—though the company says some efficacy was clinically meaningful.
Still, there is reason to be excited by Tuesday’s news, which follows decades of struggle by researchers trying to fight RSV. That includes a disastrous vaccine trial in the 1960s, which caused vaccinated children to develop more severe disease from an RSV infection and led to the tragic death of two infants.
An oft-overlooked virus
It may seem newly famous, but RSV—or respiratory syncytial (sin-SISH-uhl) virus—is a common, seasonal virus that has long posed a grave risk to infants and toddlers. Nearly everyone is infected during childhood, and most experience only a mild respiratory illness. But for a small fraction of children, particularly those under 5, it can turn life-threatening. RSV sends around 3.6 million to the hospital each year worldwide and kills over 100,000 children under 5 each year. Deaths most often occur in infants under 6 months old and among children in lower-income countries.
In the US, RSV is among the leading causes of hospitalization for children under 5. A typical RSV season sends between 58,000 and 80,000 children under 5 to the hospital and kills between 100 to 300, the Centers for Disease Control and Prevention estimates.
Researchers have been working for decades to prevent and treat RSV. But a dark cloud loomed over the field for years, halting progress. It formed in the 1960s, when researchers began working on a vaccine against RSV. The experimental vaccine’s design used a standard treatment of the times—heat and a solution of formaldehyde (formalin) to inactivate the virus and “fix” or stabilize its proteins. Thus, the formalin-inactivated virus vaccine could present a whole virion to the immune system that was incapable of infecting cells, yet had all of its antigenic components essentially frozen in place so immune cells could learn to target key components.
Catastrophic candidate
But the vaccine was a tragic disaster. Not only did it fail to protect children from RSV in several clinical trials in 1966, but it also appeared to make the children more vulnerable to severe RSV.
For example, in one small US trial, researchers gave infants between the ages of 2 months and 7 months a three-dose regimen. Of 40 unvaccinated infants in a control group, 21 caught RSV during a subsequent wave of infection in the community, and only one of the unvaccinated children required hospitalization. Meanwhile, of 30 infants given the experimental vaccine, 20 went on to catch RSV, but 16 (80 percent) required hospitalization. Two of the children later died of bacterial pneumonia that developed after their RSV infections.
In the decades since, researchers worked out how exactly the vaccine caused “enhanced respiratory disease” (ERD) syndrome in the vaccinated children. First, the formalin-inactivated RSV vaccine spurred weak antibodies that only feebly blocked and neutralized live virus. This impotent response led to an accumulation of antibody-virus immune complexes that, in turn, activate exacerbating immune responses, including inflammation. The vaccine also spurred T cell responses that can cause exaggerated inflammation in the lung upon subsequent RSV infection. All of this can pave the way for severe disease and complications, such as bacterial pneumonia.
Pfizer’s RSV vaccine, given during pregnancy, protects infants from severe illness
The data was announced in a news release and has not yet been published or peer reviewed. But it offers a glimmer of good news in the middle of a brutal and early RSV season that has contributed to a wave of respiratory illness that is overwhelming many pediatric hospitals.
“We’re very hopeful everything can be done in time to vaccinate mothers before the next RSV season,” said Annaliesa Anderson, chief scientific officer of vaccine research and development at Pfizer. “We’re about to come into a very heavy RSV season. We’re seeing hospitals filling up. Everyone appreciates the urgency that can really help to prevent this.”
RSV is a common respiratory illness, and most people experience it as common cold-like symptoms. But in young infants, whose airways are smaller, the virus can be life-threatening — and it is the leading cause of hospitalization for babies.
Unlike vaccines that are given directly to infants, the Pfizer shot provides protection through an indirect route. Antibodies are naturally passed down to infants during pregnancy, so maternal vaccination is a way of giving babies a temporary, but immediate, shield of immune protection. Vaccines for influenza, diphtheria, tetanus and pertussis are also given as maternal immunizations.
The Pfizer vaccine, given early in the third trimester, was 69 percent effective after birth in preventing severe cases of illness that required medical attention over six months. It was even more effective within the first three months after birth, probably reflecting antibody levels that naturally drop off over time.
Researchers also measured whether the vaccine prevented infant medical visits caused by RSV, including cases that were not severe. Those results did not reach statistical significance, but suggested that the vaccine could cut medical visits due to RSV in half during the first six months after birth.
The company said that there were no major safety concerns for babies or vaccinated individuals, but that data will be closely scrutinized by regulators. There were 7,400 pregnant people in the trial, and infants were followed for at least a year.
Barney Graham, a vaccine expert at Morehouse School of Medicine whose work with Jason McLellan at the University of Texas at Austin underlies much of the progress in the RSV field, said the news was gratifying.
“I think this is a big step for protecting babies against RSV and improving overall lung health,” Graham said. “Overall, it’s an exciting time for RSV. It’s also a troubling time, because you see how the patterns of infection have been changed by covid, and we’re having an earlier, bigger season this year than we have for a couple of years — and it’s causing a lot of hospitalization and misery for people.”
Two promising tools to prevent RSV in infants could soon be available, if regulators agree they are safe and effective. In addition to Pfizer’s maternal vaccine, AstraZeneca and Sanofi showed that a single dose of a monoclonal antibody could protect infants from RSV for five months. That drug, nirsevimab, was recently recommended for approval in Europe. Two vaccines for older adults have also showed success, from Pfizer and GSK.
Many pediatricians have been waiting for tools to fight RSV for decades. Early efforts to create a vaccine backfired disastrously, causing babies to develop an enhanced illness if they became infected and casting a shadow over the field.
If both a preventive monoclonal antibody treatment and a vaccine soon become available, it will give physicians options — and lead to debates about how the different tools should be used.
“I’m so thrilled at where the field is right now. I think there are many, many people out there in the world who share my excitement,” said Ruth Karron, a pediatrician and professor of international health at the Johns Hopkins Bloomberg School of Public Health, who is working on a different vaccine that could be given directly to young children, to protect them after the first six months.
“The difference this year is the general public for the first time is probably eagerly awaiting an RSV vaccine, because they’re seeing firsthand just how much of a problem RSV can be.”
Why it’s easier to find Pfizer’s updated COVID boosters than Moderna’s
Vaccinators around the country are reporting weeks-long delays in shipments of Moderna’s updated COVID-19 vaccine boosters. The delays come after the Food and Drug Administration flagged concerns at a facility contracted to fill the Moderna’s new shots into vials.
The wait stems from an Indiana plant operated by Catalent, which is one of two firms that has been bottling Moderna’s vaccine in the U.S.
Following an inspection, the FDA this month faulted the Moderna contractor for falling short in its quality control procedures, and failing to “thoroughly investigate” batches discovered to be contaminated. Since September 2020, the company had received 179 complaints over impurities in its vials.
The FDA’s inspection had tied up emergency use authorization of all the updated doses filled and finished by Catalent for Moderna.
However, citing “potential supply limitations,” Moderna submitted additional data to the regulator asking to clear 10 batches of its vaccine from Catalent’s plant.
The FDA granted that request on Tuesday. Moderna told the regulator it plans to “submit similar requests for additional batches on a rolling basis” to free up millions more doses.
“This authorization was based on FDA’s determination that the batches met all applicable specifications, following a careful review of information provided by Moderna about the manufacture of these batches. The agency has no concerns with the safety, effectiveness, or quality of these batches,” FDA spokesperson Michael Felberbaum said in a statement.
News of the FDA’s move was reported first by The Washington Post.
“We anticipate that these availability constraints will be resolved in the coming days. We continue to be on track to meet our committed delivery of 70 million doses of our updated, bivalent vaccine by the end of this year,” Moderna spokesperson Christopher Ridley said in a statement.
Chris Halling, a spokesperson for Catalent, said the FDA had “found no issues related to the safety or efficacy of the Moderna product” during its routine inspection, adding that production of the vaccines “has continued without interruption.”
“Catalent takes all observations very seriously, and we have already begun employing all necessary steps to address each observation as quickly as possible,” Halling said.
The delays have resulted in a lopsided rollout of the updated boosters since they were formally cleared for use on September 1.
Some states have moved to suspend ordering for the Moderna doses, citing the delays. Others have urged residents not to wait for the Moderna shots.
A spokesperson for the Department of Health and Human Services says 26 million doses of the updated shots have been distributed. Americans are eligible to receive either shot, “regardless of which primary vaccine they received.”
“We anticipate that Moderna supply will continue to increase in the coming days and weeks. Pfizer’s updated COVID-19 vaccine is already widely available across the country,” said the HHS spokesperson.
A spokesperson for Pfizer said the company has supplied “more than 21 million doses,” which works out to some 80% of the U.S. supply so far. The company plans to ship “up to 100 million” doses by the end of November.
“Pfizer’s Kalamazoo, MI site alone is currently manufacturing 10-15 million doses per week with capacity to increase this considerably,” said Julia Michelle Cohen, the Pfizer spokesperson.
Nationwide data on how many the shipped doses of vaccine have gone into arms is expected to be released this Thursday, a Centers for Disease Control and Prevention official said at a recent webinar hosted by the COVID-19 Vaccine and Equity Project.
Early figures from the agency posted last week suggested vaccinations climbed to the highest levels since early May, as the updated boosters began to roll out.
The FDA’s move also comes as the regulator has said it is working to vet data submitted by Moderna as well as Pfizer and its partner BioNTech on updating booster shots for younger children.
In planning documents shared with health departments this week, the CDC said it expects the bivalent shots could soon be cleared for use “in early to mid-October” for younger age groups.
Moderna’s shots could be a simpler option for family doctors and pharmacies, given the company plans to use the same vaccine vials as adults for children down to six years old.
“One question that I’ll answer right now, that may come up is, when are we going to have these vaccines for younger children? And I think we can say that, for the age range of five and up, that’s a couple of weeks away,” the FDA’s Dr. Peter Marks told a virtual event with the National Foundation for Infectious Diseases on Monday.
“And for the youngest children, it’s probably later this fall to early winter as the data come in and we can review it,” said Marks.
Dr. Fauci talks COVID after Pfizer’s Paxlovid treatment
The quadruple-vaccinated Dr. Anthony Fauci said he is experiencing a “much worse” COVID rebound after being treated with Pfizer’s antiviral medication Paxlovid.
The 81-year-old chief medical adviser to the White House revealed his health struggles while speaking remotely at the Foreign Policy Global Health Forum on Tuesday.
The nation’s leading infectious disease expert tested positive for COVID-19 on June 15 and was initially experiencing mild symptoms, according to a statement released at the time by the National Institutes of Health.
When his condition took a turn for the worse, he began a five-day course of Paxlovid, which was granted an emergency use authorization by the Food and Drug administration in December 2021 to treat high-risk COVID patients in an effort to prevent hospitalizations and deaths.
Fauci said Tuesday that after he recovered from his initial bout with the coronavirus, he tested negative for three days, but then tested positive again on the fourth day, reported the San Francisco Chronicle.
“And then over the next day or so, I started to feel really poorly, much worse than in the first go-around,” Fauci said. “So I went back on Paxlovid and right now I am on my fourth day of a five-day course.”
The scientist added that he is feeling better but “not completely without symptoms.”
In April, the Biden administration announced it was expanding the availability of Paxlovid, touting it as “one of the most effective treatments in our nation’s medicine cabinet.”
A month later, the US Centers for Disease Control and Prevention issued a warning regarding a COVID-19 rebound after Paxlovid treatment.
The agency said some patients who were prescribed a course of Paxlovid experienced a recurrence of COVID symptoms or tested positive for the disease between two and eight days after the initial recovery.
The CDC suggested that “a brief return of symptoms may be part of the natural history of (COVID-19) infection in some persons, independent of treatment with Paxlovid and regardless of vaccination status.”
The statement added that there have been no reports of severe illness associated with rebound cases.
According to a new study by the University of California San Diego School of Medicine, COVID-19 rebound after Paxlovid treatment was likely caused by insufficient exposure to the drug because not enough of it was getting to infected cells to stop all viral replication.
The authors of the study suggested this may be due to Paxlovid being metabolized more quickly in some patients, or that the drug needs to be delivered over a longer treatment duration.
Was the fourth dose of Pfizer’s COVID-19 vaccine effective? -study
Did the Israeli government’s decision last December to allow a fourth dose of Pfizer’s COVID-19 vaccine for all those ages 60 years and over save lives or was it ineffective?
A team of researchers has concluded that it in fact saved many lives and reduced the need for hospitalization.
Researchers from the epidemiology and preventive department at Tel Aviv University’s Sackler Faculty of Medicine, Soroka University Medical Center in Beersheba, Ben-Gurion University of the Negev’s Faculty of Health Sciences and the Health Ministry’s geriatric department and Senior Shield Project studied the medical records of 24,088 elderly recipients living in long-term-care geriatric facilities who received a fourth dose, and those of 19,687 who received only three doses four months previously or earlier.
They found that getting the fourth shot was associated with 34% protection against infection, 64% to 67% against acute hospitalizations for mild-to-moderate and severe illness, and 72% against deaths.
Thus, the fourth shot definitely saved lives and reduced the need for acute hospitalization. However, protection against infection with the Omicron variant was only “modest,” they wrote.
The data covered 43,775 residents, almost 68% of them women, whose mean age was 80.1 years. The median follow-up time was 73 days. More than seven days after being vaccinated with the fourth dose, SARS-CoV-2 infection was detected among 4,058 fourth-dose vs. 4,370 third-dose recipients.
These findings, they asserted, are relevant to the control of the COVID-19 pandemic not only in Israel but around the world, especially among elderly people living in long-term-care geriatric institutions.
Israel was the first country to introduce a third vaccine dose five months or more after the second one. That program was associated with high protection against overall SARS-CoV-2 infection, COVID-19 hospitalizations and deaths in the general population.
“Elderly residents of long-term-care facilities are at high risk for severe and fatal COVID-19, with reduced immunity… and rapid decline in the immune response after two vaccine doses,” the team wrote.
“Elderly residents of long-term-care facilities are at high risk for severe and fatal COVID-19, with reduced immunity … and rapid decline in the immune response after two vaccine doses.”
Research team
Israel’s actions
To protect this population, the Israeli government launched a designated task force, Senior Shield, which was responsible for preventing and controlling COVID-19 in geriatric facilities, including providing personal protective equipment, screening and early detection of healthcare workers and vaccinating residents.
The vaccination campaign for the third dose in geriatric patients began in August 2021 and was associated with high vaccine uptake and rapid declines in the incidence of SARS-CoV-2 infection and COVID-19 hospitalizations. Protection by this third dose – compared with the second dose given five or more months earlier – was 89% against infection, 92% to 93% against COVID-19 hospitalization and 96% against COVID-19 deaths during the Delta variant surge.
The Omicron variant, first identified in Israel last November, became the dominant variant just two months later. By the beginning of December 2021, a marked rise in COVID-19 infections was observed, which was also found among fully vaccinated people.
Rise of COVID-19
To contain this substantial surge, the Health Ministry approved giving the fourth dose on the last day of 2021; it was initially meant for those in long-term-care geriatric facilities and later expanded to the general population 60 years or older.
Indeed, among the general Israeli population 60 years or older, wrote the team, the protection granted by the fourth dose was estimated at 45% to 50% against SARS-CoV-2 infection. It was 62% to 71% effective against severe COVID-19 during the period of one to four weeks after vaccination compared with vaccination with three doses four months or more earlier.
U.S. doctors reconsider Pfizer’s Paxlovid for lower-risk COVID patients
May 28 (Reuters) – Use of Pfizer Inc’s (PFE.N) COVID-19 antiviral Paxlovid spiked this week, but some doctors are reconsidering the pills for lower-risk patients after a U.S. public health agency warned that symptoms can recur after people complete a course of the drug, and that they should then isolate a second time.
More quarantine time “is not a crowd-pleaser,” Dr. Sandra Kemmerly, an infectious disease specialist at Ochsner Health in New Orleans, told Reuters. “For those people who really aren’t at risk … I would recommend that they not take it.”
Use of Pfizer’s Paxlovid, authorized to treat newly infected, at-risk people in order to prevent severe illness, has soared as infections have risen. More than 162,000 courses were dispensed last week – compared with an average of 33,000 a week since the drug was launched late last year, according to government data. Biden administration officials have pushed for wide use of Paxlovid, which the government purchased and provides free.
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But higher use has also come with more reports from people who say their symptoms eased with Paxlovid only to return a few days after finishing a five-day regimen of the pills.
On Tuesday, the Centers for Disease Control and Prevention, citing case reports and concerns that relapsed patients could spread the virus, issued its advisory that Paxlovid users should isolate for a second five days if symptoms rebound. read more
“I am shying away from giving it to people who are very low- risk, and are not terribly ill, particularly people who are vaccinated and boosted,” said Dr. Bruce Farber, chief of public health and epidemiology for Northwell Health. He said he is still recommending Paxlovid for people who have significant health conditions or are over age 75.
Pfizer, in an email, said it is monitoring the data, but believes the return of detectable virus is uncommon and not uniquely associated with its drug. “We have not seen any resistance emerge to date in patients treated with Paxlovid,” a spokesperson said.
Paxlovid’s emergency authorization stipulates that it should be used only for newly infected people with risk factors, but doctors said many others have sought out a prescription.
“We get a lot of requests – maybe somebody is traveling and they want to take it just in case,” said Dr. Tara Vijayan, infectious disease specialist at UCLA Health in Los Angeles. “We are not offering it as a just-in-case.”
The CDC also said it is unclear whether cases of rebound symptoms have anything to do with Paxlovid, or are simply part of the natural trajectory of COVID-19. The agency did not flag any specific concerns about health effects.
“COVID historically has had this sort of stuttering course – people will feel better one day and then feel worse the next day, but I can say we haven’t seen these rebound symptoms with other COVID treatments,” said Vijayan, referring to therapies such as monoclonal antibodies.
“The patients that do get a rebound, it’s usually very mild,” said Dr. Earl Strum, medical director of employee health at Keck Medicine of USC in Los Angeles.
Some question how much Paxlovid is helping given the high number of people vaccinated or previously infected with COVID-19. The drug was authorized in December after a study in unvaccinated, high-risk COVID patients with conditions like diabetes showed an 88% reduction in hospitalization or death.
At the time, the Delta variant was prevalent, but it has since been displaced by the more transmissible Omicron.
“There’s so much more baseline immunity around. There’s still a lot of infections, but they’re not nearly as severe,” Northwell’s Farber said.
He estimated the rate of Paxlovid-related COVID rebounds at around 10% – higher than the 3-4% rate cited by Pfizer in its trials of the drug.
Jason Gallagher, an infectious diseases expert at Temple University’s School of Pharmacy, said the rebounds do not detract from the drug’s utility. “It prevents you from going to the hospital … if you become symptomatic after you stop taking it, that stinks, but the overall drug was a success,” he said.
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Reporting by Deena Beasley in Los Angeles
Editing by Caroline Humer and Matthew Lewis
Our Standards: The Thomson Reuters Trust Principles.