[Originally published: March 10, 2022. Updated: Jan. 10, 2024]
Note: Information in this article was accurate at the time of original publication. Because information about COVID-19 changes rapidly, we encourage you to visit the websites of the Centers for Disease Control & Prevention (CDC), World Health Organization (WHO), and your state and local government for the latest information.
Paxlovid, the pill that has become the go-to treatment for COVID-19 treatment, was granted full approval in May by the Food and Drug Administration (FDA) for the treatment of mild-to-moderate COVID-19 in adults at high risk for severe disease, including hospitalization and death. The drug also remains available to everyone 12 and older (weighing at least 88 pounds) who has mild-to-moderate disease and is at high risk for severe disease under an FDA Emergency Use Authorization.
Paxlovid is an oral antiviral pill that can be taken at home to help keep high-risk patients from getting so sick that they need to be hospitalized. So, if you are eligible to take the pills, you can take them at home and lower your risk of going to the hospital.
The drug, developed by Pfizer, had an 89% reduction in the risk of hospitalization and death in unvaccinated people in the clinical trial that supported the EUA, a number that was high enough to prompt the National Institutes of Health (NIH) to prioritize it over other COVID-19 treatments. Studies outside of the laboratory have since confirmed Paxlovids effectiveness among people who have been vaccinated. Its cheaper than many other COVID-19 drugs (at this time, U.S. residents eligible for Paxlovid will continue to receive the medicine at no charge), and it is expected to work against the latest Omicron subvariants.
It's really our first efficacious oral antiviral pill for this virus, says Scott Roberts, MD, a Yale Medicine infectious diseases specialist. It shows clear benefit, and it really can prevent hospitalization and death in people who are at high risk.
FDA approval will allow Paxlovid to remain available for adults indefinitely. Meanwhile, Pfizer continues to gather pediatric data to submit for FDA approval in children at a future date.
As far as convenience, this medication is considered an improvement over treatments like remdesivir (approved by the FDA in October 2020), which is administered by intravenous (IV) injection. The FDA also granted an EUA in December to a pill from Merck called molnupiravir (Lagevrio), but some studies suggest that molnupiravir has only a 30% reduction in the risk for hospitalization and death from COVID-19.
We asked Yale Medicine infectious diseases experts common questions about Paxlovid. Below are their responses.
California has rules to keep workplaces safe from COVID-19. Learn how you can keep yourself protected.
Employers must follow workplace safety and health regulations to protect workers. That includes protecting workers from COVID-19.
Follow the California Division of Occupational Health and Safety (Cal/OSHA) COVID-19 Prevention Prevention Non-Emergency Regulations and Frequently Asked Questions to keep your workplace safe. They cover:
Workers who are at much higher risk of being exposed to someone with an infectious disease spread in the air are protected by the Cal/OSHA Aerosol Transmissible Disease (ATD) Standard.
Examples include workers in healthcare and correctional facilities. Visit the ATD Safety & Health Fact Sheet to learn more.
Youre protected by California laws that prohibit retaliation for exercising workplace rights. If your employer retaliates because you requested exclusion pay, file a retaliation complaint. Contact the California Labor Commissioners Office for help.
If long COVID affects your ability to work, you may be able to ask your employer for accommodations to help you do your job. Visit theUS Department of Labor websitefor more information.
Learn more about resources on the Post-COVID conditions (Long COVID) Coronavirus COVID-19 Response (ca.gov) page and the CDPH Post-COVID Conditions (Long COVID) Questions & Answers (ca.gov).
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Data on how well and how long mRNA COVID vaccines protect adolescents from severe COVID-19 infections are scarce, but newly published findings from a large, matched cohort study from young people in four Nordic countries found high efficacy that lasted as long as a year.
The study's main focus was the impact of primary vaccination on hospitalizations at 6- and 12-month follow-up, but the researchers also looked at the effect on lab-confirmed infections. The team reported its findings yesterday in Pediatrics. The group also examined the effectiveness of the Moderna vaccine and the impact of mixed doses of Pfizer-BioNTech and Modernacalled heterologous vaccinationfor the primary schedule.
The study was conducted during a time that spanned both Delta and Omicron SARS-COV-2 circulation, from May 28, 2021, to April 30, 2023. From nationwide registers in Denmark, Finland, Norway, and Sweden, researchers included 526,966 adolescents ages 12 to 17 who had gotten two mRNA vaccine doses, each with a matched unvaccinated control.
COVID vaccination in the age-group began in the four countries in the summer and fall of 2021. However, in early October of that year, Denmark, Finland, and Norway halted use of the Moderna vaccine due to safety concerns. For the same reason, Sweden barred its use in all people younger than 30.
For Pfizer-BioNTech, vaccine effectiveness (VE) against hospitalization was high, at 72.6% (95% confidence interval [CI], 62.5% to 82.7%) at the 6-month mark. Compared with unvaccinated adolescents, risk difference (RD) was2.8 (95% CI, 4.5% to 1.0%) per 10,000 vaccinated after 6 months. For Moderna, VE and RD were 86.0% (95% CI, 56.8% to 100.0%) and 2.1 (95% CI, 4.0 to 0.2), and for heterologous vaccination, VE and RD were 80.7% (95% CI, 58.0% to 100.0%) and 5.5 (95% CI, 15.5 to 4.6).
At 12 months, VE against hospitalization for Pfizer-BioNTech was 65.6% (95% CI, 55.4% to 75.8%), for Moderna was 91.0% (95% CI, 72.6% to 100.0%), and for heterologous vaccination was 82.5% (95% CI, 63.6% to 100.0%).
The team found that results were similar for both Delta- and Omicron-dominant periods.
Hospitalizations were rare, which isn't surprising, given the younger healthy population. They ranged from fewer than 5 in vaccinated kids to 37 in their unvaccinated peers across 6 months of follow-up and from 8 to 140 at 12 months in the respective groups.
The authors said the VE findings against hospitalization in adolescents were similar to earlier data for the Pfizer-BioNTech vaccine, but only a few studies have estimated VE 6 months after the primary vaccine series. They noted that earlier studies were mixed on durability of protection.
When the team looked at VE against lab-confirmed COVID at 6 months, the estimated it was 22.2% (95% CI, 4.5% to 39.8%) for Pfizer-BioNTech, 3.6% (95% CI, 37.0% to 44.1%) for Moderna, and 27.8% (95% CI, 1.1% to 56.7%)for mixed vaccination. Findings were similar for the group's 12-month estimate.
The authors included a caveat, however, that estimating VE against infection had limitations. In the early months of 2022, some Nordic countries shifted away from routine polymerase chain reaction (PCR) testing as home antigen testing became more common.
The researchers said their estimate of COVID VE in teens needs to take into account absolute case reductions, especially considering the low number of hospitalizations, even in unvaccinated adolescents.
They note that vaccination prevented 3.5 to 6.2 COVID hospitalizations per 10,000 over 12 months, which for comparison is much lower than the 27.1 per 10,000 found in a Finnish study of children ages 6 weeks to 18 months who received the 10-valent pneumococcal vaccine.
"Therefore, the impact of primary vaccine schedules for COVID-19 seemed to be modest among the healthy adolescents in terms of absolute numbers," they wrote.
A recent study has revealed the effectiveness of COVID-19 vaccines in preventing long COVID.
While vaccines have proved effective to prevent severe COVID-19, their impact to prevent long-term symptoms have not yet been fully understood. But a research team at the University of Oxford'sNuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS) has found that vaccination against COVID-19 consistently reduced the risk of long COVID symptoms.
Dani Prieto-Alhambra, Professor of Pharmaco- and device epidemiology, who led the study explained: Vaccines against COVID-19 were rapidly developed to tackle the pandemic and to date eight vaccines have received authorisation from international regulators including EMA and MHRA, with billions of doses delivered to date. These vaccines proved to be highly effective in preventing severe COVID-19 but its known that around 1 in 10 people suffer from persistent symptoms, what we call long COVID. We wanted to assess if COVID vaccines had any impact on long COVID symptoms, and obtained funding from the National Institute for Health and Care Research (NIHR) to conduct a study to research this.
Published in The Lancet Respiratory Medicine, the study conducted extensive analyses using primary care electronic health records from the UK, Spain, and Estonia. The team examined data from more than 20 million vaccinated and unvaccinated individuals and identified cases of long COVID based on specific criteria defined by the WHO (World Health Organisation). The study focused on adults who were registered for at least 180 days in each respective country.
Across the different cohorts analysed, the researchers observed a significant decrease in the occurrence of long COVID among vaccinated individuals compared to those who were unvaccinated.
Dr Annika Jodicke, Senior Pharmacoepidemiologist and study co-lead, said: We were able to demonstrate how both vaccines prevented the development of persistent COVID symptoms. Additionally, we compared different vaccinations and found that the BNT162b2 vaccine (BioNTech/Pfizer) provided better protection against long COVID compared to the ChAdOx1 vaccine (Oxford/AstraZeneca).
Dr Marti Catala, Senior Data Scientist and lead author of the manuscript, added: Thanks to our international collaborations, we replicated our analyses using data from Spain and Estonia. Our findings were consistent across the three countries and many different populations, emphasising the critical role that vaccination plays in protecting individuals from the long-term consequences of COVID-19.
Funded by the NIHR through a specific call to research long COVID prevention and treatment, and with partial support from the NIHR Oxford Biomedical Research Centre (BRC), the study offers valuable insights to inform public health strategies and vaccination campaigns worldwide.
The study, 'The effectiveness of COVID-19 vaccines to prevent longCOVID symptoms: staggered cohort study of data fromthe UK, Spain, and Estonia', is published inThe Lancet Respiratory Medicine.
Bivalent (two-strain) COVID-19 vaccines help protect against COVID-19related thromboembolic events, including strokes, embolisms, and heart attacks, more so than monovalent (one-strain) vaccines, according to a study today in Morbidity and Mortality Weekly Report.
The study was based on outcomes seen among Medicare enrollees ages 65 and older and adults ages 18 years or older with end-stage renal disease (ESRD) receiving dialysis. Outcomes among those who had received a bivalent mRNA COVID-19 booster were compared to patients who had only the monovalent COVID-19 primary vaccine series.
The Medicare beneficiaries, who did not have compromised immune systems (ie, were immunocompetent), entered the study on September 4, 2022. Researchers updated vaccination status daily. Follow-up continued until March 4, 2023, or a COVID-19related thromboembolic event.
The authors defined a thromboembolic event as an ischemic stroke, venous thromboembolism, or myocardial infarction from 7 days before through 30 days after COVID-19 diagnosis.
Among 12,706,176 Medicare beneficiaries aged 65 years and older who had previously received an original COVID19 vaccine, 5,683,208 (44.7%) received a bivalent dose. Among 78,618 Medicare beneficiaries aged 18 and older years with ESRD receiving dialysis, 23,229 (29.5%) received a bivalent dose, including 7,239 (31.2%) aged 18 to 64 years and 15,990 (68.8%) aged 65 years or older.
For both those 65 and older and those with ESRD, getting a bivalent booster was associated with getting a seasonal flu vaccine, and an original monovalent booster.
During the study period, 22,001 Medicare beneficiaries had a COVID-19related thromboembolic event, as did 1,040 ERSD beneficiaries. The researchers calculated an adjusted vaccine effectiveness (VE) against COVID-19related thromboembolic events among immunocompetent beneficiaries aged 65 years and older of 47%, with lower VE estimates more than 60 days after bivalent vaccine receipt (42%) compared with VE estimates 7 to 59 days after bivalent vaccine receipt (54%).
For those with ESRD, adjusted VE against COVID-19related thromboembolic events was 51%, with lower VE estimates more than 60 days after bivalent vaccine receipt (45%) than 7 to 59 days after bivalent vaccine receipt (56%).
"These findings can be interpreted as the incremental benefit of a recent bivalent dose compared with earlier receipt of original monovalent doses and are consistent with reported lower rates of COVID-19related thromboembolic events among vaccinated than among unvaccinated persons," the authors said.
These findings can be interpreted as the incremental benefit of a recent bivalent dose compared with earlier receipt of original monovalent doses.
Moreover, the findings are notable in light of a vaccine safety signal detected in January 2023 by the Centers for Disease Control and Prevention, which suggested a possible link between receipt of a Pfizer-BioNTech bivalent COVID-19 mRNA vaccine and an increased the risk for an ischemic stroke event in the 21 days following vaccination in people age 65 and older.
That signal has not been proven, and a review of additional studies has not provided clear and consistent evidence of a safety problem with ischemic stroke and bivalent mRNA COVID-19 vaccines, the authors said.
In conclusion, the investigators said their study suggests adults over the age of 65 and those with ESRD should remain up to date on boosters.
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A team of scientists, led by Duke-NUS Medical School, has discovered a potential intranasal vaccine candidate that provides improved, longer-lasting immunity against SARS-CoV-2 viruses compared to when given as an injection. By triggering an immune response directly at the point of entry, the intranasal vaccine candidate enhanced long-term immune memory of the virus, which could translate to a reduced need for booster shots.
There is growing evidence that intranasal vaccines provide greater protection at mucosal surfaces, making this a vaccination route that could reduce breakthrough infections and subsequent transmission of the virus.
To delve into this, the research team, which includes collaborators from Duke-NUS' parent universitiesDuke University and the National University of Singaporeamong others, compared the immune responses from nasal and subcutaneous administration of the vaccine, as well as immunity from the vaccine with and without the use of adjuvantssubstances added to vaccines to enhance the body's immune response.
Published in eBioMedicine, the findings showed nasal administration of the vaccine candidate boosted mucosal antibody response, as expected. Additionally, and more importantly, it enhanced longer-lasting mucosal and systemic immune protection through preferential induction of airway-resident T cells and central memory T cells.
"Our data show that, compared to subcutaneous vaccination, the intranasal route improved the response of certain immune cells, known as T cells, which reduced disease severity," explained Associate Professor Ashley St John, from Duke-NUS' Emerging Infectious Diseases Program, who is the lead author of the study.
"Not only that, but it also resulted in a greater number of T central memory cells compared to subcutaneous vaccination, which could lead to longer-lasting protection."
T central memory cells play a vital role in safeguarding the body upon re-exposure to a virus. They enhance the immune system's memory, inducing long-lasting protective immune responses. This ability to retain this long-term memory of the virus suggests less need for a pathogen challenge to achieve the same level of protection against the virus, potentially translating into fewer boosters.
The research team also found that the use of adjuvants in the vaccine to promote immune response influenced the characteristics of T cells, as well as their activation and production of cytokinestiny proteins that regulate cell communication and control inflammationwith different adjuvants leading to different T-cell responses.
Another notable finding from the study was that a type of antibody, called IgG, that circulates widely in the bloodstream is more effective at neutralizing variants of the virus, including newly emergent ones, when induced through the nasal vaccine route. These discoveries provide important scientific evidence that improved immunity responses from both T cells and IgG antibodies contribute to greater and long-lasting protection of intranasal vaccines from COVID-19.
"While the acute phase of the pandemic may be behind us, the rise of new variants, including JN.1, which has triggered an increase in hospital admissions locally, demonstrates that we have room in our arsenal of vaccines and treatments for even better tools. This study shows that mucosal vaccination holds promise for improving COVID-19 vaccine efficacy with potentially fewer boosters needed," said Professor Patrick Tan, Senior Vice-Dean for Research at Duke-NUS.
A patent has been filed on the discovery, which covers the invention of the vaccine composition formulated for mucosal delivery, paving the way for an industry partnership to potentially develop mucosal vaccines against COVID-19 and other pathogens that also target mucosal surfaces.
More information: O'Neill A, Mantri CK, Tan CW, Saron WA, Nagaraj SK, Kala MP, Joy CM, Rathore APS, Tripathi S, Wang L-F, St. John AL. Mucosal SARS-CoV-2 vaccination of rodents elicits superior systemic T central memory function and cross-neutralising antibodies against variants of concern. eBioMedicine (2024). DOI: 10.1016/j.ebiom.2023.104924.
Journal information: EBioMedicine
The World Health Organization (WHO) recently prequalified the novel oral poliovirus vaccine type 2 (nOPV2), the first time the group has ever prequalified a vaccine that is being used under the emergency use listing, the Global Polio Eradication Initiative (GPEI) announced yesterday.
Rollout of the new vaccine began in March 2021, and nearly 1 billion doses have already been administered across 35 countries. WHO prequalification, though, paves the way for more countries to receive the vaccine, which has played a key role in stemming outbreaks involving type 2 variant poliovirus (cVDPV2).
In GPEI's statement, WHO Director-General Tedros Adhanom Ghebreyesus, PhD, called the prequalification a historic public health milestone. "Novel oral polio vaccine type 2 has blazed a trail for other new vaccines that address critical health emergencies, and its use demonstrates the utility of the EUL mechanism in helping to rapidly get new products to where theyre needed most."
GPEI added that WHO prequalification streamlines regulatory approval in countries that need it.
The vaccine's maker is Bio Farma Indonesia, and regulators in Indonesia have fully licensed it. It was developed by an international consortium that included the Bill and Melinda Gates Foundation, the United Kingdom's National Institute for Biological Standards and Controls (NIBSC), theUS Centers for Disease Control and Prevention, the US Food and Drug Administration, PATH, and the University of California at San Francisco.
Oral polio vaccine (OPV) is widely used in campaigns in lower-resource countries, because it is easy to store and transport and easy to administer. However, the attenuated virus in the oral vaccine can mutate and become virulent again, especially in settings where uptake is low.
GPEI said nOPV2 is as safe and effective as its predecessor, monovalent type 2 oral polio vaccine (mOPV2), but is more genetically stable. Estimates after 3 years of clinical use suggest nOPV2 is 80% less likely to seed new variant polio outbreaks.
Nigeria was one of the countries hardest hit by cVDPV2 outbreaks and has played a key role in nOPV2 rollout, GPEI said. Over the past 3 years, use of the vaccine reduced Nigerian cases by 85%. Globally, 325 cases were reported in 2023, down sharply from 689 cases in 2022.
In today's Medical Minute, we learn more about whether medical marijuana can cause an increased risk of irregular heartbeat and how a universal COVID-19 vaccine could help protect Americans from pandemics in the future.
Sunday, January 14th 2024, 9:38 am
By: News On 6
In today's Medical Minute, we learn more about whether medical marijuana can cause an increased risk of irregular heartbeat and how a universal COVID-19 vaccine could help protect Americans from pandemics in the future.
Two new US studies suggest that the bivalent (two-strain) Pfizer/BioNTech mRNA COVID-19 vaccine offered children and adolescents good protection against severe outcomes such as hospitalizationduring Delta and Omicron predominance and that vaccine-induced antibodies can neutralize Omicron BA.2.86 but that the subvariant has features linked to severe symptoms.
The bivalent vaccine was replaced by a monovalent (single-strain) version in fall 2023.
In an observational comparative-effectiveness study, researchers from the University of Pennsylvania and Children's Hospital of Philadelphia (CHOP) analyzed data on vaccine effectiveness (VE) against infection and severe disease from 250,000 never-infected COVID-19 patients at pediatric health systems participating in the national PEDSnet collaboration. About half of participants had received at least one dose of the Pfizer vaccine during the Delta and Omicron waves that began in mid-2021 and 2022, respectively.
The results were published today in the Annals of Internal Medicine.
Study participants were included in one of three cohorts: adolescents aged 12 to 20 years during the Delta wave (77,392 participants; 58.2% vaccinated) and children aged 5 to 11 years (111,539 participants; 45.2% vaccinated) and adolescents aged 12 to 20 (56,080 participants; 38.0% vaccinated) during the Omicron period.
During Delta, estimatedVE was 98.4% against infection among adolescents, with no significant waning after the first dose and no significant difference in cardiac complications between vaccinated and unvaccinated groups. During Omicron, estimated VE against infection in children was 74.3%. Higher VEs were seen against moderate or severe illness (75.5%) and intensive care unit (ICU) admission (84.9%).
Although the pandemic has been declared over, the risk of COVID-19 is present throughout U.S. communities.
In adolescents, estimated VE against Omicron infection was 85.5% (84.8% against moderate or severe COVID-19 and 91.5% against ICU admission). VE against Omicron waned 4 months after dose one and then leveled off. Vaccinated participants were at lower risk for cardiac complications during this period.
"Our assessment of vaccine effectiveness across diverse outcomes underscores the vaccine's pivotal role in reducing SARS-CoV-2 transmission, minimizing COVID-19related sick leaves, and alleviating economic burdens during the pandemic," the study authors concluded.
In a UPenn news release, co-senior author Christopher Forrest, MD, PhD, of UPenn and CHOP, noted that COVID-19 vaccine clinical trials enrolled children and adolescents last. "Although the pandemic has been declared over, the risk of COVID-19 is present throughout U.S. communities," he said. "Thus, more information is needed on effectiveness of vaccination delivered to children and adolescents during more recent time periods."
For a cell-culture study published yesterday in Cell, Ohio State University researchers analyzed neutralizing antibodies in serum samples from healthcare providers who received three monovalent vaccine doses or two monovalent doses followed by a bivalent booster and from first responders infected with COVID-19 during the Omicron XBB.1.5 wave.
They compared the ability of neutralizing antibodies to prevent infection by BA.2.86, the FLip XBB-derived variant, the wild-type virus, and several other variants. BA.2.86 is the ancestor of the currently dominant Omicron JN.1 variant and has more than 30 spike-protein mutations than its close Omicron relatives.
If you have less severe disease, the antibodies generated by infection are lowalmost 10-fold lower than vaccine-induced antibodies.
Bivalent vaccine-induced serum antibodies produced in healthcare providers were more efficient at neutralizing BA.2.86 than at neutralizing other Omicron variants, including XBB.1.5, which the authors said explains why BA.2.86 didn't cause a huge surge. But the three monovalent vaccines and previous XBB.1.5 infection were only marginally effective in preventing BA.2.86 infection.
Also, they found that BA.2.86 can infect the cells that line the lower lungs and fuse with the host cell membrane more efficiently, two features tied to severe COVID-19 symptoms.
"People who have had a COVID-19 infection should remember that omicron variants are less virulent compared to prior variants such as delta, meaning they don't make most people very sick," senior author Shan-Lu Liu, MD, PhD, of Ohio State, said in a university news release. "If you have less severe disease, the antibodies generated by infection are lowalmost 10-fold lower than vaccine-induced antibodies. That is why you cannot rely on natural infection alone for immunity."
Because the bivalent COVID-19 vaccine is less effective against BA.2.86 than the currently available monovalent version, Liu advised getting a booster.
