OPINION:
The smoke is finally clearing from the coronavirus battle.
The picture emerging is one of shortcomings in government-approved vaccines, which are raising serious questions about past and present assurances that the mandated drugs were and are safe and effective.
Experts disputing the efficacy of these novel medications must be heard and the reliability of these treatments validated before officials repeat the mistakes made at the height of the COVID-19 era whenever the next pandemic is declared.
Texas Attorney General Ken Paxton may uncover some of those answers through his lawsuit against the drugmaker Pfizer for purportedly violating the Texas Deceptive Trade Practices Act.
In a 54-page complaint filed last month, Mr. Paxton writes:
In summary, Pfizer intentionally misrepresented the efficacy of its COVID-19 vaccine and censored persons who threatened to disseminate the truth in order to facilitate fast adoption of the product and expand its commercial opportunity.
After the pharmaceutical companys widespread inoculation of virus-fearing Americans in 2021, more died than in the previous year. In some locales, the lawsuit states, COVID-19 claimed more lives among the vaccinated than the unvaccinated despite the companys promotion of its new product as 95% effective.
In an abbreviated, two-month period of clinical trials, the Pfizer vaccine demonstrated robust reduction of infection risk. Yet in 2021, virus mutations emerged, including the Delta variant, resulting in a rapid drop in vaccine effectiveness.
In Israel, according to the Texas lawsuit, effectiveness plunged from 64% to 39% in a month, belying the 95% claim. The firms two-year, $75 billion windfall, the complaint asserts, is attributable to its unlawful deceptive trade practices.
Separate questions have arisen about potential danger to human health from the cutting-edge mRNA technology used to create the vaccines manufactured by Pfizer, Moderna and other pharmaceutical companies.
Robert Malone, an early mRNA technology pioneer, said in recent testimony before the British Parliament that authorities made wildly exaggerated claims that COVID-19 was killing at a frighteningly high 3.4% rate to justify the extraordinary rapid formulation and deployment of the vaccines.
Moreover, assurances that the medication would remain at the site of injection were also false, he said. Rather, the vaccines have been shown to circulate throughout the body, infiltrating various organs and remain biologically active for an undetermined period of time.
Other experts have alleged fragments of DNA used in vaccine manufacturing have been found in batches of the drugs. A preprint paper published in October by a University of Guelph researcher in Ontario, Canada, found the presence of billions to hundreds of billions of DNA molecules per dose in these vaccines, referring to the Pfizer and Moderna products. Untethered DNA has a small but not negligible potential for penetration of cells and causing a range of side effects that include cancer.
With the benefit of hindsight, inquiring minds are comparing the safe and effective vaccine assurances with the underwhelming results. What we need, in order to resolve all the controversy that swirls around these products, and whatever is the meaning of the latest data disclosure, Dr. Malone said in summation, is for governments to just be open and transparent.
Americans should demand a full examination of health effects both beneficial and harmful associated with these hastily created shots.
Amsterdam (Precision Vaccinations News)
The European Commission (EC), the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) today published the first version of the Union List of critical medicines, which includes vaccines.
As of December 12, 2023, the List contains more than 200 active substances of medicines for human use, considered critical for healthcare systems, for which continuity of supply is a priority and shortages should be avoided.
The List reflects the outcome of the review of 600 active substances taken from six national lists of critical medicines andwill be expanded in 2024 andupdated yearly.
Inclusion in the List does not mean that the medicinewill likely experience a shortage soone. It implies that preventing shortages is particularly important as a shortage could cause significant harm to patients and pose essential challenges to health systems.
A medicine or vaccine is considered critical if used in serious diseases and cannot be easily replaced by other products in case of a shortage.
Doctors in Singapore are calling on people to vaccinate and to put on a face mask to reduce the usual year-end increase in acute respiratory infections, including COVID-19, influenza and the common cold.
Both Healthway Medical, the largest general practice chain with more than 120 clinics, and Parkway Shenton with 55 GP clinics, say they have seen a 30% increase in respiratory infections, according to a report by The Straits Times on December 12.
Raffles Medical with 43 GP clinics has also noticed an increase in such ailments, the report added.
The latest Ministry of Health (MOH) data for the week ending December 2 showed an average of 2,970 cases a day at Singapores 25 polyclinics against a five-year median of 2,009 daily cases for 2018 to 2022 for this time of the year.
While this is lower than the 3,000 to 3,500 a day in the pre-pandemic years, it comes on the back of almost three years of low infection rates due to precautions taken against COVID-19. In 2020 and 2021, polyclinics were seeing fewer than 1,000 cases a day in early December.
Polyclinics treat about 20% of acute cases in the primary care setting, with the 1,800 GP clinics handling the rest.
For the same week, more than 32,000 people were diagnosed with COVID-19 about 460 were hospitalised and nine needed intensive care, adding significantly to the bed crunch at public hospitals.
Professor Hsu Li Yang, an infectious diseases expert at the National University of Singapores Saw Swee Hock School of Public Health, said: During this holiday season, as upper respiratory tract infections including COVID-19 cases rise, it is important to be mindful of others. Wear a mask in crowded places, stay home if unwell, and get the latest flu jab as well as a COVID-19 booster to avoid disrupting your travel plans. Doctor Jonathan Tan, a family physician at Healthway, added: We usually see more respiratory infections during the year-end. However, this year we are seeing an even larger increase in the number of upper respiratory tract infections.
Fortunately, the majority of cases are mild and can be treated in an outpatient setting, he said. He too advised staying updated with Influenza and COVID-19 vaccinations and to mask up, especially in crowded places, as this can reduce the chances of catching air-borne bugs.
COVID-19 vaccines are free in Singapore, as is the Influenza vaccine for those who have signed up for Healthier SG, the national scheme introduced in 2023 to encourage people to stick to one family doctor who can provide preventive care to keep them healthy.
The actual number of people with Influenza is relatively low, with the majority suffering from the common cold.
The MOH, which tracks Influenza infections to spot possible pandemics, said: The proportion of patients with Influenza-like illness among the polyclinic attendances for acute respiratory infection is 0.5%. Out of this small number with Influenza-like illness, only 11.5% tested positive for the flu virus over the past four weeks.
Dr. Tan said people who feel sick should promptly test for COVID-19 at home. If they test positive, there is the option of taking antiviral medications such as Tamiflu. This will reduce the severity of symptoms.
Doctor Edwin Chng, Parkway Shentons medical director, said: Those with risk factors, including the elderly and immunocompromised people, should see a doctor for proper assessment. He said people should practise good hygiene which most people were doing during the pandemic years such as hand washing and not touching their face with their hands, as this could spread diseases like the common cold, COVID-19 and the flu.
Doctor Chng Shih Kiat, medical director at Raffles Medical, said some patients seen at its clinics needed to be prescribed antivirals, though the majority of patients had relatively mild symptoms.
To avoid getting sick, he advised people to stay healthy and eat a balanced diet with an adequate intake of fruits and vegetables.
It is also important to get ample rest and stay hydrated. Exercise regularly, but do not over-exert with overzealous exercise routines. When travelling, wear a mask, especially in crowded places, the broadsheet had Dr. Chng as saying.
Published: Dec. 13, 2023 at 8:01 a.m. ET
By Will Feuer
Shares of Moderna and other makers of Covid-19 vaccines were dragged lower after rival Pfizer warned that it expects revenue from its Covid-19 products to fall next year.
Moderna shares were down nearly 5% at $74.51 in premarket trading, following Pfizer shares, which were more than 6% lower. Shares of Moderna have already fallen...
By Will Feuer
Shares of Moderna and other makers of Covid-19 vaccines were dragged lower after rival Pfizer warned that it expects revenue from its Covid-19 products to fall next year.
Moderna shares were down nearly 5% at $74.51 in premarket trading, following Pfizer shares, which were more than 6% lower. Shares of Moderna have already fallen nearly 57% this year.
American depositary receipts tied to shares of Germany-based BioNTech, which has partnered with Pfizer on its Covid-19 vaccine, fell about 4% to $95.00 in the premarket session. The stock is down about 34% this year.
Shares of Novavax also fell about 1% to $5.25 in premarket trading, adding to a decline of about 48% this year.
Earlier Wednesday, Pfizer issued revenue and earnings outlook for next year that fell below Wall Street analysts' expectations. The miss was largely driven by declining sales of the company's Covid-19 vaccine and its Paxlovid treatment.
Write to Will Feuer at Will.Feuer@wsj.com
A high-dose recombinant influenza vaccine (Flublok Quadrivalent) was more protective than an egg-based standard-dose influenza vaccine in adults, according to results of a cluster-randomized, observational study.
Among adults ages 50 to 64, the high-dose vaccine was 15.3% more effective in preventing influenza than the standard-dose vaccine (95% CI 5.9-23.8, P=0.002) and 15.7% more effective against influenza A (95% CI 6.0-24.5, P=0.002), reported Nicola Klein, MD, PhD, from the Kaiser Permanente Vaccine Study Center in Oakland, California, and colleagues in the New England Journal of Medicine.
Although the relative benefit of the high-dose vaccine appears to be modest, "reducing breakthrough influenza cases by 15% would provide a substantial public health benefit, especially during more severe influenza seasons," Klein told MedPage Today in an email.
Georges Benjamin, MD, executive director of the American Public Health Association in Washington, D.C., agreed. "The high-dose vaccine increased protection by about 15% overall," he told MedPage Today in an interview. "When you think about the fact that we don't usually get more than 40% to 50%, maybe 60% efficacy in a good year to begin with, that's a nice boost. The study authors convinced me, that for this age range, it does provide better protection than the standard dose," he said.
Researchers did not find that the recombinant vaccine was significantly more protective than the standard-dose vaccine against influenza-related hospitalization. However, "a post hoc analysis combining hospitalization for PCR-confirmed influenza and hospitalization for community-acquired pneumonia yielded a relative vaccine effectiveness of 19.7% (95% CI 2.8-33.7)," the authors wrote.
The Advisory Committee on Immunization Practices (ACIP) currently recommends high-dose influenza vaccines for adults ages 65 and older. However, for people younger than 65, ACIP does not preferentially recommend any age-appropriate influenza vaccine over another. Recommended options for this age group include inactivated influenza vaccine, recombinant influenza vaccine, or live attenuated influenza vaccine.
The high-dose recombinant influenza vaccine evaluated in this trial is FDA-approved for adults 18 and older, and is three times the dose of standard-dose influenza vaccines.
Participants included all members of a large U.S.-based integrated healthcare delivery system over seven geographic regions. The study population included 1,630,328 people from the ages of 18 and 64 who were vaccinated for influenza in the healthcare system -- 632,962 received the high-dose recombinant vaccine and 997,366 received the standard-dose vaccine.
Although the study was observational, it had a unique cluster-randomized design "intended to emulate a randomized trial," the authors wrote. Facilities in each region were assigned to Block A or Block B to even out differences in facility size. To achieve balance between the two vaccine groups, facilities alternated on a weekly basis between administering the high-dose recombinant vaccine and the standard dose vaccine. Patients were unaware of which vaccine they received.
During the study period of the 2018-2019 and 2019-2020 influenza seasons, 1,386 cases of PCR-confirmed influenza were diagnosed in the recombinant-vaccine group and 2,435 cases in the standard-dose group. Among those who were ages 50 to 64, 559 participants (2 cases per 1000) tested positive for influenza in the recombinant-vaccine group and 925 participants (2.34 cases per 1000) tested positive in the standard-dose group.
The study data were limited to two influenza seasons and relative vaccine effectiveness may vary across seasons, the researchers acknowledged. In addition, participants included in the study might not be representative of other U.S. populations.
Katherine Kahn is a staff writer at MedPage Today, covering the infectious diseases beat. She has been a medical writer for over 15 years.
Disclosures
The study was funded by Sanofi.
Klein has received grants from GlaxoSmith Kline, Merck, Pfizer, and Sanofi Pasteur.
Co-authors reported no relevant disclosures.
Benjamin also reported no relevant disclosures.
Primary Source
New England Journal of Medicine
Source Reference: Hsiao A, et al "Recombinant or standard-dose influenza vaccine in adults under 65 years of age" N Eng J Med 2023; DOI: 10.1056/NEJMoa2302099.
ARLINGTON, Va., BETHESDA, Md., CHICAGO and DALLAS During National Influenza Vaccination Week (December 4-8, 2023), leading public health organizations are encouraging everyone to get a flu shot if they have not already done so. The flu is more than an inconvenience: it can lead to hospitalization, worsening of chronic medical conditions or even death. An annual flu vaccine is the best way to help prevent complications from the flu. [1]
The American Heart Association, the American Lung Association, the American Diabetes Association and the National Foundation for Infectious Diseases are teaming up to reach those who have not yet received a flu vaccine this season with an important message: its not too late to protect yourself and others by getting your flu shot.
Even if you are not at higher risk for a serious case of the flu, getting vaccinated helps protect those around you who are more vulnerable, like people age 65 and older and people with chronic conditions like heart disease or stroke, diabetes or lung disease. According to the U.S. Centers for Disease Control and Prevention, in recent years, about 9 out of every 10 people who were in the hospital due to the flu had at least one underlying medical condition.[2]
Although the best time to get vaccinated in the U.S. is in the fall, before flu viruses begin spreading in your community,[3] experts say those who havent gotten a flu vaccine yet should do so as soon as possible.
Virtually everyone can benefit from a flu shot, and thats especially true for people with chronic conditions like heart disease and diabetes who have weakened immune systems and have worse flu if they get it, said Eduardo Sanchez, M.D., M.P.H., FAHA, the American Heart Associations chief medical officer for prevention. Even if you feel well now or think you can fight off the flu if you get it, it is important to get vaccinated to protect the loved ones around you who may be at higher risk for dangerous complications.
Last fall, we saw cases of the flu increase earlier than typical years. Thankfully, flu vaccination provided substantial protection for people across the U.S., said Albert Rizzo, M.D., chief medical officer for the American Lung Association. We know that getting a flu shot is the best way to help protect yourself, your family and your community against flu and severe illness from the flu. And this protection is especially important for certain people at increased risk for developing serious complications such as those living with chronic medical conditions including asthma, chronic obstructive pulmonary disease (COPD) and other chronic lung diseases.
If you are over 65, you should ask about getting one of the three flu vaccines that are specifically recommended for your age, because studies have shown they trigger a better immune response in older adults than standard flu vaccines. However, if one of the specific vaccines is not available, you should still get whatever vaccine is available, as they all provide some protection and can lessen complications from flu. Additionally, it is safe to get the flu shot at the same time as an updated COVID-19 vaccine or booster for COVID-19.
In recent years, almost a third of the people hospitalized due to the flu had diabetes,[4] said Robert Gabbay, MD, PhD, the ADAs chief scientific and medical officer. The threat of flu and COVID is particularly high to someone with diabetes, especially considering many people who live with diabetes have other complications like heart disease and kidney disease. Staying up to date on all annual vaccines and the COVID-19 vaccine is recommended for everyone who is eligible, especially those living with diabetes and other chronic illness.
According to a National Foundation for Infectious Diseases (NFID) survey, more than 1 in 4 US adults (28%) who are at higher risk for flu-related complications, including older adults and people with chronic health conditions, said they were not planning to get vaccinated this season. This is concerning because this season is likely to be more complex, as in addition to flu and COVID-19, respiratory syncytial virus (RSV) is also circulating, said NFID Medical Director Robert H. Hopkins, Jr., MD. Fortunately, we now have vaccines to help protect against all 3 of these viruses. Getting vaccinated is critical to help protect yourself, your family, and your community from serious disease and potential complications.
The American Heart Association, the American Lung Association, the American Diabetes Association and the National Foundation for Infectious Diseases all offer educational resources on their websites about the burden of flu and the importance of vaccination for people with chronic health conditions.
Sources:
By Eve Glazier, M.D.,
and Elizabeth Ko, M.D. Andrews McMeel Syndication
Hello, dear readers, and welcome to our monthly letters column. With chillier weather in much of the country, were getting a lot of questions about flu and COVID-19 prevention. And to everyone who wrote in last month to share your frustration with (and adverse effects from) the return to standard time, you are not alone. The switch prompted some interesting questions about sleep, which well address in future columns. And now, your letters.
Lets begin with the COVID-19 vaccine. The days of the two-shot series, which marked the rollout of the vaccine at the end of 2020, are over. Today, the CDC recommends that everyone 5 years of age and older receive a single dose of what is being called the updated vaccine. And while these are sometimes being referred to as boosters, a reader and physician from Spokane points out thats not exactly accurate. My understanding is that the new COVID-19 vaccine formulation is not considered a booster, she wrote. A person who has never received a COVID-19 vaccine in the past can get the protective benefit of this single vaccination.
Yes, that is correct. The updated vaccine, which protects against the newer variants of the virus, is a stand-alone shot. A single dose offers protection, regardless of previous vaccination status. It is expected that COVID prevention will follow the familiar pattern of the flu vaccine. That is, a single shot, updated each year. Anyone older than 6 months is eligible to get an age-appropriate dose of the updated vaccine. If you have previously received the bivalent vaccine, it is recommended that you wait at least two months before getting the updated shot.
Another popular topic is if its OK to get the COVID-19 and flu vaccines at the same time. The answer is yes. In fact, an interesting study in a group of health care workers in Massachusetts suggests that doing so may boost immune response. A month after being vaccinated for the flu and COVID, the group who received both vaccines at the same time were found to have higher levels of COVID-fighting antibodies than those who got their shots on separate days. With COVID and flu seasons underway, the important thing is to get vaccinated. The shots lower your risk of getting sick and help protect against severe disease if you do.
We will wrap up with a few words about RSV, which is short for respiratory syncytial virus. In healthy adults, it usually causes mild, coldlike symptoms. Most people recover quickly. But in infants, whose immune systems are still developing, RSV can cause severe symptoms and lead to hospitalization. This year, for the first time, an RSV vaccine has become available. Although manufacturing issues originally limited availability of the vaccine, that bottleneck is now easing. The vaccine protects against severe disease. Parents should check with their pediatricians for availability.
Thank you, as always, for taking the time to write to us. Its wonderful to know that you find the columns interesting, thought-provoking and useful.
Send your questions to askthedoctors@mednet.ucla.edu.
As the season for family gatherings approaches, the Maine Center for Disease Control and Prevention is urging Mainers to get vaccinated against respiratory diseases.
Maine CDC is asking Mainers to make sure they have the current vaccines for influenza, COVID-19, and respiratory syncytial virus.
Vaccination and other common-sense precautions, including testing for COVID-19, helps keep our families and communities particularly individuals who are older or immune compromised safe during this season of travel and get-togethers, said Maine CDC Director Dr. Puthiery Va.
As of December 12 of this year, Maine CDC reported 85 patients statewide had been hospitalized with COVID-19, with nine in critical care and four on a ventilator. More than 210,000 people in Maine have the latest vaccine against COVID-19.
Maine CDC also indicated that as of the week of Dec. 9, there were 14 patients hospitalized with the flu in Maine. More than 396,000 people in Maine have gotten the flu shot. Data on RSV was not available.
The latest COVID-19 and flu vaccines are available to anyone age six months and older. MaineCDC recommends the RSV vaccine for adults aged 60 and older, pregnant women and children less than one-year-old.
Most pharmacies offer all three vaccinations, and most vaccines are covered by health insurance or through the US Centers for Disease Control and Preventions Bridge Access Program. Some health care providers also offer vaccinations or walk-in vaccine clinics. All three vaccines may be administered at the same time.
As we head into the winter, we want to remind Maine people that vaccination against COVID-19, the flu, and if youre eligible RSV remains the best gift to yourself and your loved ones this holiday season, said Va.
In addition to vaccinations, Maine CDC offered the following tips to stay safe:
Stay home when you are sick
Wash your hands
Cover your coughs and sneezes
Increase airflow and ventilation, when possible
Avoid close contact with people who are sick
Avoid touching your eyes, nose, and mouth
Clean and disinfect surfaces and objects
Respiratory illness season is on its way, and Sanford Health doctors are urging patients to get vaccinated.
With influenza and RSV (respiratory syncytial virus) typically starting in the fall and peaking from December to February, now is the time to get those preventive shots. There also is a new monovalent COVID-19 vaccine for the 2023-24 season.
Get your shots: Make an appointment
The flu vaccine is among the safest and most widely used medical products, said Susan Hoover, M.D., an infectious disease specialist at Sanford Health in Sioux Falls, South Dakota. Vaccination can help prevent you from getting influenza, help you be less ill, or prevent hospitalization due to the flu. The time to get a flu shot is now, and you can get it on the same day as an updated COVID-19 vaccine.
Patients vaccinated against flu in the Southern Hemisphere, where the flu season is winding down, lowered their chances for severe influenza illness, the Centers for Disease Control and Prevention reported.
In addition to vaccination, the CDC urges everyone to take other measures to protect against flu and its potentially severe complications, including avoiding close contact with people who are ill.
The CDC recommends flu vaccinations for everyone 6 months and older, especially those at higher risk of complications including pregnant people, older adults and young children.
An updated COVID-19 vaccine is available for ages 6 months and older.
Sanford Health is now administering the new monovalent COVID-19 vaccine labeled the 2023-2024 COVID-19 vaccine, which targets the omicron variant XBB.1.5. This vaccine replaces the most recent bivalent COVID vaccine that came out in 2022.
While new COVID-19 strains circulate, the 2023-2024 COVID-19 vaccine is expected to provide cross-protection this respiratory illness season.
The CDC recommends everyone 6 months and older receive the updated COVID-19 vaccine if its been at least two months since their most recent dose.
For the first time, RSV immunizations are available for certain groups.
A single dose of RSV vaccine will be given to adults ages 60 and older. Vaccination is recommended for individuals who have a weakened immune system from illnesses or medications, chronic conditions like heart or lung disease, or live in a nursing home.
A single dose of RSV vaccine is recommended for pregnant women between 32 and 36 weeks of pregnancy right before or during RSV season to help protect babies for the first six months of their lives.
A new antibody treatment is recommended for infants younger than 8 months old who are born during or entering their first RSV season. Except in rare circumstances, most infants younger than 8 months of age do not need the RSV immunization if they were born 14 or more days after their mother got the RSV vaccine.
Infants and children 8-19 months old who are at increased risk for severe RSV disease and entering their second RSV season should also receive a dose.
Right now, a nationwide shortage of one brand of this antibody treatment has led the CDC to advise two groups to get it first:
The goal is to immunize all infants for RSV, and a similar RSV immunization is available. Talk to your childs provider about the benefits of both options and which one may be right for your child.
Find a clinic near you or make an appointment:
Posted In COVID-19, Flu, Healthy Living, Immunizations
State Rep. Jessica Gonzlez has announced that her office will host a free COVID-19 and flu vaccination clinic in Cockrell Hill on Saturday, Dec. 16, from 10:30 a.m. to 1 p.m., at the Cockrell Hill City Council Chambers, 4125 W. Clarendon Drive.
Gonzlezs office is offering the vaccination clinic in partnership with Dallas County Health and Human Services, the city of Cockrell Hill, Andrews Distributing Company and Ben E Keith. The clinic will take place
Gonzlez said in a written statement, I want to thank our partners for joining our office to bring COVID-19 and flu vaccines to House District 104; 75211 is a zip code disproportionally affected by COVID-19, so it is imperative to bring more vaccination opportunities to this community.
Getting vaccinated is the best way to protect yourself and your family from contracting the flu or COVID-19, she continued. Receiving the COVID-19 vaccine has been shown to help protect against severe disease, hospitalization and death. I encourage everyone to get vaccinated.
Pfizer and Moderna COVID-19 vaccines, along with the flu vaccine, will be available for anyone over the age of 6 months. Minors must be accompanied by a parent or legal guardian. No appointment is required.
Those who have health insurance are asked to bring their insurance card and ID with them. Those without insurance can still get either vaccine at no charge.
Dallas County residents receiving a vaccine for COVID-19 will receive a $25 Walmart gift card from the Dallas County Health and Human Services, while supplies last.
Tammye Nash
