Pfizer CEO Albert Bourla discusses the pharma company's next big drug after its COVID vaccine on 'The Claman Countdown.'
Pfizer on Tuesday reported its first quarterly loss since 2019 as demand for its COVID products dwindled.
Sales of the company's coronavirus vaccine Comirnaty dropped 70% during the third quarter compared with the same period a year earlier. Sales of its COVID-19 treatment Paxlovid fell 97% from the same period a year ago, the company said.
Pfizer, which announced a $3.5 billion cost-cutting program earlier this month, slashed $9 billion off its 2023 sales forecast after agreeing to take back nearly 8 million Paxlovid treatment courses from the U.S. government.
Pfizer expects Paxlovid to remain available for free to Americans through the end of the year.
PFIZER SAYS IT'S EYEING A $110 TO $130 LIST PRICE FOR COVID-19 VACCINE IN U.S.
Pfizer's Paxlovid is displayed on July 7, 2022, in Pembroke Pines, Florida. (Joe Raedle/Getty Images / Getty Images)
The company posted a net loss of 42 cents per share for the third quarter. Excluding one-time items, Pfizer reported a loss of 17 cents per share compared with analysts' expectations for a loss of 34 cents, and a profit of $1.78 per share a year ago.
Pfizer also said it will book a $5.6 billion charge for write-offs related to its COVID inventory.
NEW PFIZER PILL CHALLENGING OZEMPIC WILL BE A HUGE, HUGE DRUG: DR. MARC SIEGEL
The company noted that the drop in revenue from COVID products would be partially offset by "expected operational growth" from its non-COVID-19 in-line portfolio, including new product and indication launches and recently acquired products.
Pfizer CEO Albert Bourla said the company is "encouraged by the strong performance of Pfizers non-COVID products in the third quarter of 2023."
Revenue from Pfizers non-COVID products grew 10% operationally during the quarter.
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In particular, Bourla noted recent milestones including the approval and launch of its RVS vaccine Abrysvo in the European Union as well as the U.S. approval and launch of Elrexfio, a medication used to treat adults with multiple myeloma.
Pfizer, one of the producers of the COVID-19 vaccine, is developing a new vaccine designed to protect against Lyme disease. (REUTERS/File Photo / Reuters)
Bourla said the company is also making headway on its acquisition of cancer-focused biotech company Seagen Inc.
By Ahmed Aboulenein and Michael Erman
WASHINGTON (Reuters) -Over 15 million people in the United States, around 4.5% of the population, had received the updated COVID-19 shots by Oct. 27, a Department of Health and Human Services (HHS) spokesperson said on Wednesday, lagging behind last year's vaccinations.
Close to 23 million people had received updated boosters as of Oct. 26 last year, U.S. Centers for Disease Control and Prevention (CDC) data shows. The 2022 fall vaccination campaign started around 10 days earlier than this year's.
"As of Oct. 27, more than 15 million Americans have received the updated COVID-19 vaccine and over 19 million vaccines have shipped to pharmacies and other locations, with 91% of Americans 12 years and older living within 5-miles of a vaccination site," the spokesperson said in an emailed statement.
The updated shots from Pfizer and BioNTech, Moderna or Novavax are single-target vaccines aimed at the XBB.1.5 Omicron subvariant of the coronavirus, which was dominant in the U.S. for much of this year but has since been overtaken by other variants as the virus evolves.
Rollout of the Pfizer and Moderna shots began in earnest after the CDC recommended them on Sept. 12. The rollout of last year's updated shots targeting two virus variants started about 10 days earlier, and by Oct. 26, around 23 million Americans had rolled up their sleeves for one of them.
U.S. public health officials have expressed hope that Americans will welcome the new vaccines as they would an annual flu shot. But demand for COVID vaccines has dropped sharply since 2021, when they first became available.
Around 56.5 million people, or 17% of the U.S. population, received last year's version of the vaccines.
(Reporting by Ahmed Aboulenein in Washington and Michael Erman in New York; Editing by Chizu Nomiyama and Aurora Ellis)
Rachel Chamberlain, RRT, received her flu vaccination because of her experience treating patients with complications from the flu.
I have witnessed what the flu can do to patients, Chamberlain says. That is why its so important to get your flu vaccination.
Have you received yourflu vaccination yet? Employees and volunteers can get their flu vaccinationand updated COVID-19 vaccinationfrom 7:30 a.m. to 4:30 p.m. Monday through Friday at the University Employee Health Clinic or at one of these scheduled flu vaccination clinics.
All UI Health Care employees and volunteers are required to receive the influenza vaccine or decline it into comply with this years mandatory flu vaccination campaign.
Learn more about how to get vaccinated on ourflu landing page.
Suffolk County reported the following information related to COVID-19 on October 30, 2023
According to CDC, hospital admission rates and the percentage of COVID-19 deaths among all deaths are now the primary surveillance metrics.
COVID-19 Hospitalizations for the week ending October 21, 2023
Daily Hospitalization Summary for Suffolk County From October 30, 2023
NOTE: HOSPITALS ARE NO LONGER REPORTING DATA TO NYSDOH ON WEEKENDS OR HOLIDAYS.
Fatalities 10/30/23
COVID-19 Case Tracker October 28, 2023
Note: As of May 11, 2023, COVID-19 Community Levels (CCLs) and COVID-19 Community Transmission Levels are no longer calculatable, according to the Centers for Disease Control and Prevention.
* As of 4/4/22, HHS no longer requires entities conducting COVID testing to report negative or indeterminate antigen test results. This may impact the number and interpretation of total test results reported to the state and also impacts calculation of test percent positivity. Because of this, as of 4/5/22, test percent positivity is calculated using PCR tests only. Reporting of total new daily cases (positive results) and cases per 100k will continue to include PCR and antigen tests.
COVID-19 Vaccination Information
Last updated 5/12/23
Vaccination Clinics
As of September 12, 2023, the Suffolk County Department of Health Services is not authorized to offer COVID-19 vaccines to ALL Suffolk County residents.
The department will offer the updated vaccine to only uninsured and underinsured patients through New York State's Vaccines for Children program and Vaccines for Adults program, also known as the Bridge Access Program.
Those with insurance that covers the COVID-19 vaccine are encouraged to receive their vaccines at their local pharmacies, health care providers offices, or local federally qualified health centers.
The department has ordered the updated COVID-19 vaccine and will announce when the vaccine becomes available.
FOR HEALTHCARE PROVIDERS
New York State Links
CDC COVID Data Tracker Rates of laboratory-confirmed COVID-19 hospitalizations by vaccination status
For additional information or explanation of data, click on the links provided in throughout this page.
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We found that study participants who received mRNA vaccines as primary series had the lowest reinfection rate and the highest increase in antibody titers. Those who received inactivated virus vaccines had the highest reinfection rate and the lowest rise in antibody titers. In terms of individual brands of COVID-19 vaccine, there were no identified cases of probable reinfection among participants given inactivated Vero Cells and Ad26.COV2.S vaccines as primary series. However, these two brands had the lowest number of recipients (only one and nine participants received the inactivated Vero cells vaccine and Ad26.COV2.S vaccines, respectively). We observed the highest reinfection rate among vaccinees who received Sputnik V, followed by CoronaVac.
We noted that the highest reinfection rate was observed among participants who received Sputnik V (Gamaleya) despite the large rise in antibody titer after primary series vaccination. This may be due to other variables that influence reinfection rates, including age, co-morbidities, employment, and exposure to COVID-19 [10].
The reinfection rates of the unvaccinated and partially vaccinated study participants were paradoxically lower compared to those who were fully vaccinated, regardless of type of vaccine. This may be explained by the epidemiologic context in relation to the timing of vaccination, as shown in Fig.2. There were two COVID-19 surges in the Philippines during the study periodthe Delta variant surge in August-October 2021 and the Omicron variant surge in January-February 2022. Of the 64 cases of probable reinfection, 6 (9.4%) occurred during the Delta variant surge while 39 (60.9%) occurred during the Omicron variant surge. During the time of these surges, majority of study participants were already fully vaccinated. Thus, the lower reinfection rates of the unvaccinated and partially vaccinated study participants may reflect the lower incidence of COVID-19 infection in the Philippines during the start of the study period.
Epidemiological context in the Philippines and the vaccination status of study participants. (Image modified from the https://doh.gov.ph/covid19tracker) [11]. BE1=first blood extraction at day 21, BE2=second blood extraction at day 90, BE3=third blood extraction at day 180, BE4=fourth blood extraction at day 270, BE5=fifth blood extraction at day 360,
Our findings are consistent with other studies that found that higher antibody levels were associated with a lower risk of COVID-19 infection [12]. In our study, those who received mRNA vaccines primary series had the largest rise in antibody titers and correspondingly, the lowest reinfection rate. These findings are also consistent with the results of systematic reviews showing that vaccine effectiveness against COVID-19 infection was highest for the primary series of mRNA vaccine [4, 5].
The mRNA vaccines consist of a lipid nanoparticle enveloping an mRNA molecule that encodes the viral Spike protein. This vaccine induces antigen-specific follicular helper T cell development in the germinal centers of the draining lymph nodes, which would lead to B cell activation, antibody isotype switching, affinity maturation, and formation of plasma cells and memory B cells [13]. This mechanism of action closely resembles the immune response to a natural infection, which may explain why mRNA vaccines stimulate higher antibody titers and consequently, produce greater effectiveness against COVID-19 infection, hospitalization, and death [14].
We also observed that the GMT ratio of all types of vaccine exceeded 4. A four-fold increase in antibody titers is generally the minimum rise interpreted as an adequate antibody response [15]. This supports the findings of studies in other countries that the various types of vaccines demonstrate acceptable immunogenicity despite variation in the actual magnitude of humoral response [16]. Among the seven brands of COVID-19 vaccines received by the study participants, only the inactivated Vero cells vaccine had a GMT ratio less than 4. However, only 1 participant received this vaccine.
Among the study participants who received booster doses, the largest GMT ratios were observed among those with inactivated virus vaccine as the primary series, likely due to the lower pre-booster titer compared to those who received viral vectors and mRNA vaccines as primary series. An inverse relationship with pre-immunization titer level and degree of humoral response has been demonstrated in other studies, where a higher pre-vaccination titer is associated with a lower rise in antibody post-vaccination [17].
The GMT ratio was higher with heterologous boosters after inactivated virus and viral vectors primary series compared to homologous boosters. However, among those who received mRNA vaccine as primary series, the GMT ratio was higher for those given homologous boosters compared to heterologous boosters. These findings are consistent with studies in other countries reporting better immunogenicity for heterologous compared to homologous boosters for inactivated virus vaccines, and conversely, better immunogenicity for homologous boosters for mRNA vaccines [18, 19]. The lower GMT ratio of heterologous booster for mRNA vaccine may be due to the use of viral vectors as the booster in 5 out of the 20 participants. As shown in our study and in other published studies, viral vector vaccines generally result in a smaller rise in antibody titers compared to mRNA vaccines. Our findings suggest that the administration of mRNA vaccines as booster, whether as a heterologous booster or homologous booster, results in larger rise in antibody titers.
In this study, adverse events following immunization were more frequently reported among mRNA and viral vector vaccines compared to inactivated virus vaccines. This finding is consistent with other studies [6, 20]. Increased vaccine reactogenicity has been associated with higher post-vaccination antibody levels [21]. This was observed in this study, with participants who received inactivated virus vaccines having the lowest GMT ratio and also the lowest percentage of adverse events following immunization.
Our study had the following limitations. First, in the primary cohort study we conducted, we could not do laboratory confirmation of reinfection due to the unavailability of routine genomic testing for symptomatic patients. Instead, an adjudication committee determined whether reported events were probable reinfections. Hence, the reinfection rates we report in this study refer to probable reinfection rather than confirmed reinfection. Furthermore, reinfection rates in the main cohort study were probably underestimated because testing via RT-PCR or antigen test was encouraged but not provided for free for participants with symptoms consistent with COVID-19. Some symptomatic study participants refused to undergo testing. The study was also unable to detect cases of asymptomatic reinfection. Thus, the reinfection rates reported in this study are likely to be underestimated.
Another limitation is that the antibody titers measured were binding antibodies, not neutralizing antibodies. Tests for neutralizing antibodies are ideal since these are the antibodies that directly interfere the binding and uptake of virus to the host cells [21]. At the time the cohort study was being conducted, there were no certified biosafety level 3 laboratories in the country. However, studies have demonstrated neutralizing antibodies strongly correlate with RBD-specific binding antibodies, and that RBD-specific binding antibody titers can serve as surrogate measures for neutralizing titers [22].
Another limitation in this study is the variation in the timing of antibody titer determination in relation to vaccination, since antibody tests were performed at fixed time points based on the initial COVID-19 infection. Means and standard deviations of the number of interval days between the antibody determination and vaccination were reported to provide appropriate context to the results.
Moreover, the semi-quantitative laboratory test used in the study had an upper limit of detection of 250 U/mL. We performed 10-fold dilution according to manufacturer recommendations to increase the upper limit of detection to 2,500 U/mL. However, several results still exceeded 2,500 U/mL. We performed 100-fold and 1,000-fold dilutions to increase the upper limit of detection to 250,000 U/mL; however, the resulting values at this higher range may have diminished accuracy.
Another limitation is the presence of several confounding variables that affect reinfection rate and antibody titers aside from vaccination. Due to these issues, and the small sample size of the completed cohort study, this study was designed as a descriptive study and the results are intended to be exploratory in nature. Inferential statistics was not done.
Furthermore, the completed cohort study primarily aimed to determine symptoms of COVID-19 reinfection during the follow-up calls. Participants were also asked if they received the COVID-19 vaccine, and the type, brand and date of vaccination. From this recorded data, adverse events following immunization were extracted. However, this is prone to reporting bias. Although COVID-19 symptoms have several similarities as systemic adverse events following immunization, other symptoms such as rashes, flushing or local erythema which were not directly asked by the researchers may have been missed if the information was not volunteered by the study participants. Moreover, data for this study was heavily reliant on the completeness and accuracy of the data recorded in the completed cohort study.
PROVIDENCE, R.I. [Brown University] The global COVID-19 vaccination campaign saved 2.4 million lives in 141 countries and could have saved about 670,000 more had the vaccines been distributed equitably.
Thats according to a new working paper from researchers at the University of Southern Californias Schaeffer Center for Health Policy and Economics and the Brown University School of Public Health.
The National Bureau of Economic Research circulated the working paper, which has not yet been peer-reviewed, for discussion and comment this week.
The benefits of the COVID-19 vaccines are far-reaching by multiple measures, said co-author Christopher M. Whaley, an associate professor of health services, policy and practice at Brown.
"Our study shows the enormous health impacts of COVID-19 vaccines, which in turn have huge economic benefits, Whaley said. "In terms of lives saved and economic value, the COVID-19 vaccination campaign is likely the most impactful public health response in recent memory."
The findings suggest that vaccination and therapeutics are much better at preventing death than other policies aimed at slowing the spread of the virus, the authors said.
The global rollout of COVID vaccines was the largest public health campaign in human history, said co-author Neeraj Sood, a senior fellow at USCs Schaeffer Center and director of its COVID-19 Initiative. By saving 2.46 million lives, the vaccines were much more effective than non-pharmaceutical interventions such as lockdowns and mask mandates.
The researchers examined the real-world effectiveness of the global COVID-19 vaccination campaign on all-cause mortality, which accounts for both direct and indirect effects of the COVID-19 pandemic.
COVID-19 vaccination efforts fully vaccinated more than 2 billion people within the first eight months after launching, and the teams working paper is the first to estimate the effect the vaccines on excess deaths globally using observational data. The U.S. Centers for Disease Control and Prevention defines excess deaths as the difference between observed and expected numbers of deaths over a specific time period. Excess deaths are a better measure than COVID-19 death data, the researchers noted, which can be incorrectly reported.
While approximately 2.4 million deaths were averted from January to August 2021, researchers concluded that roughly 670,000 more lives could have been saved if vaccines were distributed in proportion to the populations of the 141 nations. Because of the current market-based approach, high-income countries had more immediate access to vaccines than low and middle-income countries, the authors said.
The working paper also provides an economic analysis of the global vaccination campaign, with country-specific information, with as well as comparisons with alternative distribution scenarios.
Virat Agrawal, a Ph.D. candidate at USCs Sol Price School of Public Policy, was the third co-author of the study: Establishing a global vaccine distribution policy will be crucial in preparing for future pandemics, he said.
The research was supported bythe National Institute on Aging (R01AG073286) and the Peter G. Peterson Foundation Pandemic Response Policy Research Fund.
WASHINGTON, D.C. U.S. Sen. Ron Johnson (R-Wis.), ranking member of the Permanent Subcommittee on Investigations, this week sent a letter to the top U.S. health officials at the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and National Institutes of Health (NIH) calling for transparency and complete responses to the senators numerous requests on the COVID-19 vaccines and other aspects of the pandemic.
This correspondence marks the senators 60th public letter to U.S. government agencies on the COVID-19 pandemic.
In his letter to HHS Secretary Xavier Becerra, FDA Commissioner Robert Califf, CDC Director Mandy Cohen, and NIH Acting Director Lawrence Tabak, the senator wrote, As the top U.S. health officials, and for some of you, medical doctors who have sworn to uphold the Hippocratic Oath, you and your colleagues also bear the absolute responsibility of providing patients and the American public the benefit of informed consent.
Sen. Johnson added, You and your colleagues have a duty to provide the American people with complete and transparent data regarding the safety and effectiveness of the COVID-19 vaccines. It is completely unacceptable that public health agencies have ignored requests for detailed information about vaccine lots that are associated with higher rates of adverse events and have failed to provide CDCs and FDAs complete data analyses (Proportional Reporting Ratio tables and empirical Bayesian data mining if they exist) on vaccine adverse events. The fact that the vast majority of my questions and information requests remain unanswered or outstanding only heightens my level of suspicion.
The senator emphasized the health agencies lack of transparency by highlighting his numerous oversight requests to various government agencies that remain unanswered.
Sen. Johnson noted, Individuals who willingly or reluctantly received the COVID-19 vaccines deserve to know the full truth about the adverse health outcomes they or their loved ones may face following vaccination. However, your agencies continue to obstruct my efforts to provide the public with the truth about the COVID-19 vaccines.
This letter also raised questions regarding a recently released, FDA-funded preprint study which found multiple adverse health outcomes, including seizures, associated with the COVID-19 vaccines among vaccinated children.
The results of this FDA-funded study reaffirm previous concerns about the safety of the COVID-19 vaccinesparticularly for childrenand underscore the need for federal health agencies to be transparent with the American people and responsive to Congress, the senator wrote.
In addition to reiterating the outstanding requests that health agencies have failed to address, the senator asked for new information and materials following the results of the FDA-funded study.
It is well past time for U.S public health agencies to be transparent, he concluded.
Pfizer and BioNTech announced positive topline results from a phase 1/2 clinical trial of the lead formulations of an mRNA-based combination vaccine for influenza and COVID-19. The vaccine candidates produced robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains in healthy vaccine candidates aged 18 to 64 years.
We are encouraged by these early results in our Phase 1/2 study of our combination vaccine candidates against influenza and COVID-19. This vaccine has the potential to lessen the impact of two respiratory diseases with a single injection and may simplify immunization practices for providers, patients, and healthcare systems all over the world, said Annaliesa Anderson, PhD, FAAM, senior vice president and head, vaccine research and development at Pfizer, in a press release.1
Vaccine candidates were compared to a licensed influenza vaccine and the companies own Omicron BA.4/BA/5-adapted bivalent COVID-10 vaccine administered at the same visit. Topline results of the ongoing phase 1/2 trial (NCT05596734) demonstrated a consistent safety profile for the mRNA-based combination vaccine that was similar to the companies prior COVID-19 vaccine. Further, immunogenicity results of the vaccines lead formulations demonstrated point estimates for geometric mean titer (GMT) ratios consistent with criteria applied to approved vaccines against the respective influenza and SARS-CoV-2 strains. GMT ratio point estimates for all matched influenza vaccine strains with lead formulations measured at >1 relative to a licensed quadrivalent influenza vaccine administered tandem with the Pfizer-BioNTech COVID-19 vaccine.
Pfizer and BioNTech expect to begin a pivotal Phase 3 trial in the coming months. This trial will continue evaluation of the lead formulations of their novel combination vaccine. In December 2022, the companies announced that their mRNA-based combination vaccine received Fast Track Designation from the FDA.2
The prognosis of those infected with the SARS-CoV-2 virus has improved immensely since the onset of the global COVID-19 pandemic, due to the development of a singular vaccine and the implementation of prevention and quarantine strategies. However, the virus is expected to remain a circulating severe respiratory disease in the long-term, similar to the fluwhich accounts for 1 billion infections, 5 million hospitalizations, and 650,000 deaths worldwide each year.
Studies of confirmed viral infections suggest that COVID-19 adopts a seasonal pattern with peaks in fall and winter, similar to other respiratory diseases. Coinfections, as well as consecutive respiratory infection during this period, can further increase the risk of severe illness, said Ugur Sahin, MD, CEO and cofounder of BioNTech, in the news release.1 Combination vaccines have the potential to become a mainstay of routine vaccination against respiratory diseases, especially for the vaccination of populations who have a higher risk of severe illness.
Pfizer and BioNTech expect their mRNA-based combination vaccine to become a routine part of vaccination regimens against both diseases, hailing its ability to reduce the severity of both illnesses for high-risk individuals as a great potential benefit of the development.
As cold and flu season approaches, Augusta University is taking proactive steps to ensure the health and well-being of its employees, students and the community at large.
In a bid to encourage flu vaccination, the Immunology Center of Georgia, part of the Medical College of Georgia at Augusta University, will host a flu vaccine clinic for Augusta University employees from 9-11 a.m. Friday, Nov. 10, in the Georgia Cancer Centers M. Bert Storey Research Building lobby.
The best part? No advanced sign-ups are required, making it easier than ever to get your flu shot. Employees who plan to attend the clinic should bring their employee ID and a copy of their insurance card.
Klaus Ley, MD, co-director of the Immunology Center of Georgia, emphasizes the significance of getting vaccinated against the flu.
The flu can have serious consequences, and by getting vaccinated, you protect yourself and those around you, Ley said. Its a simple yet effective way to prevent the spread of this contagious virus. Our Augusta University campus is setting the example, and we hope to encourage the entire community to get the flu vaccine.
READ MORE: Augusta University welcomes world-renowned researchers to Medical College of Georgia
The on-campus clinic offers an easily accessible opportunity for Augusta University employees to protect themselves and their colleagues from the flu this season, said Francis Toole, director of Augusta University Employee Health and Wellness.
We are committed to providing our employees with convenient and affordable access to flu vaccines, Toole said. Whether you choose to visit the clinic or our office, we are here to support your health and well-being.
In addition to the upcoming clinic, Employee Health and Wellness offers walk-in flu vaccines from 7 a.m. to 5 p.m. Monday through Friday at its office on the first floor of Professional Building One, making it easier for employees to prioritize their health. Call the clinic at 706-721-3418 for more information.
Augusta Universitys Student Health Services offered flu vaccines throughout October, including mobile clinics to students living both on and off campus, said Harrison Lamp, nurse clinician with SHS.
Our team was proud to help 750 students receive their free flu vaccinations this fall, said Lamp. Students who want to get their flu shot can call 706-721-3448 or email our clinic, and well get them more information about how to access a vaccine. SHS encourages all our students to take this step to protect themselves and their classmates.
Flu vaccination is not only a responsible choice but also a crucial step in maintaining public health. The World Health Organization records about 1 billion cases of influenza each year. Severe cases often result in hospitalizations, contributing to up to 650,000 respiratory-related deaths globally.
Worried about potential side effects from the vaccine? Ley said thats a minor concern compared to the effects of full-blown flu.
READ MORE: Augusta Universitys Immunology Center of Georgia enlists national experts to foster growth through Scientific Advisory Board
According to the Centers for Disease Control and Prevention, life-threatening allergic reactions to flu shots are very rare. While severe reactions are uncommon, it is important to let your health care provider know if you have a history of allergy or severe reaction to vaccines before getting a flu shot.
Common side effects from a flu shot could include soreness or swelling at the site of the injection, headache, low-grade fever, nausea, muscle aches or fatigue, he said. Those minor side effects are an indication your immune system is responding as it should to the vaccination. You will experience much more severe fever, aches and other symptoms if you catch the flu without being vaccinated against it.
The easy access to vaccines and the commitment of our student and employee health teams signify Augusta Universitys dedication to the well-being of our campus, Ley said. Lets all take this important step to protect our health and ensure a safer, healthier future for our community.
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