Category: Vaccine

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Mpox: Travellers advised to consider vaccine – BBC.com

August 16, 2024

Travellers should consider getting vaccinated against mpox if they will be visting affected areas in Africa, new advice says.

The European Centre for Disease Prevention and Control (ECDC) has updated its recommendations in response to outbreaks of a new strain of the virus. Other continents, including Europe, can expect some cases too, it says.

ECDC says the risk of it spreading everywhere is low, despite the World Health Organization recently declaring the mpox situation a global emergency.

The disease - formerly known as monkeypox - can be passed on by close contact with anyone with the infection.

Those who have been vaccinated against mpox in the past might only need one-top up dose, rather than two shots.

Booster vaccine doses are typically recommended every two to 10 years if a person remains at continued risk for exposure.

Mpox has killed at least 450 people in the DRC in recent months, linked to a new type or Clade called 1b.

Mpox can be passed on from person to person through:

It causes flu-like symptoms, skin lesions and can be fatal for some.

Experts say there is still a lot to learn about 1b, but it may be spreading more easily, causing more serious disease.

Pamela Rendi-Wagner from the ECDC said: "As a result of the rapid spread of this outbreak in Africa, ECDC has increasd the level of risk for the general population in the EU/EEA and travellers to affected areas. Due to the close links between Europe and Africa we must be prepared for more imported Clade 1 cases."

Currently, there are no cases of Clade 1b mpox confirmed in the UK but experts say cases can spread if international action is not taken.

A case of mpox has also been detected in Sweden after a person became infected during a stay in an area of Africa where the disease is spreading.

The ECDC recommends that public health authorities plan and prepare for quick detection of any more cases that may reach Europe.

A previous mpox public health emergency, declared in 2022, was caused by a different, milder strain called Clade 2.

Despite having effective vaccines against mpox, too few doses are currently getting to where they are needed most.

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Mpox: Travellers advised to consider vaccine - BBC.com

Pfizer and BioNTech effort to develop Covid-influenza combination vaccine sees setback – STAT

August 16, 2024

Pfizer and BioNTech said Friday that their combined mRNA vaccine candidate against influenza and Covid-19 showed a lower immune response against one type of influenza, influenza B, in a Phase 3 trial, a setback for the vaccine.

The combination vaccine met its goal in generating an immune response against influenza A and against the SARS-CoV-2 virus, which causes Covid, the companies said in a statement.

They said, however, that they are are evaluating adjustments to the combination vaccine candidate aimed at improving immune responses against influenza B and will discuss next steps with health authorities.

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Candidate malaria vaccine provides lasting protection in NIH-sponsored trials – National Institutes of Health (NIH) (.gov)

August 16, 2024

Media Advisory

Wednesday, August 14, 2024

Approach could have role in preventing malaria in pregnancy.

Two National Institutes of Health (NIH)-supported trials of an experimental malaria vaccine in healthy Malian adults found that all three tested regimens were safe. One of the trials enrolled 300 healthy women ages 18 to 38 years who anticipated becoming pregnant soon after immunization. That trial began with drug treatment to remove malaria parasites, followed by three injections spaced over a month of either saline placebo or the investigational vaccine at one of two dosages. Both dosages of the vaccine candidate conferred a significant degree of protection from parasite infection and clinical malaria that was sustained over a span of two years without the need for a booster dosea first for any malaria vaccine. In an exploratory analysis of women who conceived during the study, the vaccine significantly protected them from malaria in pregnancy. If confirmed through additional clinical trials, the approach modeled in this study could open improved ways to prevent malaria in pregnancy.

Spread by Anopheles mosquitoes, malaria parasites, including those of the species Plasmodium falciparum (Pf), can cause illness in people of any age. However, pregnant women, infants and very young children are especially vulnerable to life-threatening disease. Malarial parasitemia in pregnancy is estimated to cause up to 50,000 maternal deaths and 200,000 stillbirths in Africa each year.

The trials were co-led by investigators from the NIHs National Institute of Allergy and Infectious Diseases (NIAID) and the University of Sciences, Techniques and Technologies, Bamako (USTTB), Mali. The investigational vaccine used in both trials was PfSPZ Vaccine, a radiation-attenuated vaccine based on Pf sporozoites (a stage of the parasites lifecycle), manufactured by Sanaria Inc., Rockville, Maryland. Multiple previous clinical trials of PfSPZ Vaccine have shown it to be safe, including in malaria-endemic countries such as Mali. In results published in 2022, for example, an NIAID-sponsored, placebo-controlled trial of a three-dose regimen of PfSPZ Vaccine in Burkina Faso found that the vaccine had up to 46% efficacy that lasted at least 18 months.

In the first year of the current trial, 55 women became pregnant within 24 weeks of the third vaccine dose. Among these women, vaccine efficacy against parasitemia (whether before or during pregnancy) was 65% in those who received the lower dose vaccine and 86% in those who received the higher dose. Among 155 women who became pregnant across both study years, vaccine efficacy was 57% for those who received lower dose vaccine and 49% in those in the higher dosage group.

Women who received the investigational vaccine at either of the dosages conceived sooner than those who received placebo, although this finding did not reach the level of statistical significance, reported the investigators. The researchers speculate that the PfSPZ Vaccine might avert malaria-related early pregnancy losses since parasitemia risk during the periconception period was reduced by 65 to 86%.

Preconception immunization is a new strategy to reduce mortality for women with malaria in pregnancy, the researchers note. They plan to investigate the safety of PfSPZ Vaccine administered during pregnancy, then examine the efficacy of PfSPZ given preconception or during pregnancy in larger clinical trials. Existing measures are not protecting women from malaria in pregnancy, they added. A safe and effective vaccine is urgently needed, and our results indicate PfSPZ Vaccine might be a suitable candidate, they conclude.

The PfSPZ Vaccine Study Team was led by Alassane Dicko, M.D., of the Malaria Research and Training Center (MRTC), USTTB, Mali, Stephen L. Hoffman, M.D., of Sanaria Inc., and Patrick E. Duffy, M.D., of the NIAID Laboratory of Malaria Immunology and Vaccinology. Joint co-first authors were Halimatou Diawara, M.D., of MRTC, and Sara A. Healy, M.D., NIAID.

Additional information about the trials is available at clinicaltrials.gov using the identifiers NCT03510481 or NCT03989102.

H Diawara et al. Safety and efficacy of PfSPZ Vaccine against malaria in healthy adults and women anticipating pregnancy in Mali: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials. Lancet Infectious Diseases DOI: 10.1016/ S1473-3099(24)00360-8(2024).

Patrick E. Duffy, M.D., Chief, Laboratory of Malaria Immunology and Vaccinology, NIAID, is available to comment.

To schedule interviews, please contact Anne A. Oplinger, (301) 402-1663, niaidnews@niaid.nih.gov.

NIAID conducts and supports researchat NIH, throughout the United States, and worldwideto study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

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Health stocks are surging after the WHO declared monkeypox a global emergency – Quartz

August 16, 2024

A sign announcing monkeypox vaccination is setup in Tropical Park by Miami-Dade County and Nomi Health on August 15, 2022. Image: Joe Raedle / Staff ( Getty Images ) In This Story

The stocks of two vaccine makers surged on Thursday after the World Health Organization (WHO) upgraded a Mpox (formerly known as monkeypox) outbreak in the Democratic Republic of Congo (DRC) to a public health emergency of international concern.

Medicare patients could save $1.5 billion on 10 prescription drugs

Shares of the Denmark-based vaccine maker Bavarian Nordic spiked 17% on Thursday in Copenhagen. And the stock of the U.S. pharma company Emergent BioSolutions (EBS) rose 6% on Thursday.

Bavarian Nordic and Emergent BioSolutions are the makers of the only two vaccines that the U.S. Centers for Disease Control and Prevention (CDC) recommends for Mpox.

The stock moves come just a day after the WHO determined an upsurge in Mpox cases in the DRC and other countries in Africa constitute an international public health emergency. This was the WHOs second public health emergency for Mpox in two years.

A new variant of Mpox, known as clade Ib, has emerged and appears to be more contagious than previous variants.

The emergence of a new clade of mpox, its rapid spread in eastern DRC, and the reporting of cases in several neighbouring countries are very worrying, said WHO Director-General Tedros Adhanom Ghebreyesu in a statement. On top of outbreaks of other mpox clades in DRC and other countries in Africa, its clear that a coordinated international response is needed to stop these outbreaks and save lives.

This new variant has been found in DRC, Burundi, Kenya, Rwanda, and Uganda.

Swedens public health agency confirmed on Thursday its first case of the strain, marking the first occurrence of this strain outside of Africa.

Mpox is an viral disease that spreads between animals and people. It symptoms include fever, chills, muscle aches, and a rash that can look like pimples or blisters, according to the CDC.

Bavarian Nordics CEO Paul Chaplin told Bloomber on Wednesday that the company is able to meet the vaccine needs of this outbreak.

We have inventory and we have the capabilities. What were missing are the orders, said Chaplin

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Health stocks are surging after the WHO declared monkeypox a global emergency - Quartz

Heres what you need to know about fall booster shots for COVID-19, other respiratory illnesses – The Boston Globe

August 16, 2024

How does the current COVID surge compare to previous waves?

Though the latest numbers suggest that COVID infections are continuing to rise nationwide, infections peaked locally in mid to late July and are now slowly falling. At their apex, waste water numbers in the Boston area were roughly one-third what they were in the last winter wave, which peaked around Jan. 1, said Dr. Shira Doron, chief infection control officer for the Tufts Medicine health system and hospital epidemiologist at Tufts Medical Center.

The good news is that COVID deaths are about a quarter of what they were in January, a decoupling of severe disease, compared to case numbers that Doron attributes to increasing levels of immunity over time.

People have had multiple vaccinations, multiple infections, and the disease is going to just get less and less severe over time, she said.

With autumn quickly approaching, the falling infection rate could easily reverse, Doron noted, which highlights the importance of keeping up to date with boosters.

Local infectious disease experts anticipate updated shots to arrive sometime in September. There will be two different varieties: a traditional vaccine and two vaccines created using the newer mRNA technologies. Both will confer added protection against the latest variants of the disease, but there are some differences.

Both Moderna and Pfizer have updated the formulations of their mRNA vaccines to combat the mutations that have allowed members of the FLiRT family, a subfamily of the Omicron variant, to better evade immune detection, said Dr. Sabrina A. Assoumou, associate professor of medicine at Boston University and infectious disease physician at Boston Medical Center.

But the Novavax booster relies on an older vaccine technology that takes longer to produce, and the process started before the latest surge. It was, however, updated to protect against the JN.1 strain of the virus, an immediate predecessor to the FLiRT variants, which contains many (though not all) of the mutations that have helped FLiRT to evade existing immunity.

Though slightly less effective, Novavax vaccines may appeal to individuals who are reluctant to embrace the relatively new mRNA technology, said Assoumou.

There are probably some people out there who, for whatever reason, did not want to get mRNA vaccines and its important to also let them know that the more traditional version of vaccines is also available, Assoumou said, adding that the safety of the mRNA shots is now well established. The most important message is get something, increase your immunity so that you have some protection, because we do know that immunity wanes. The goal of these vaccines is to prevent severe disease, hospitalization, and death. And all of these vaccines should do that.

The CDCs Advisory Committee on Immunization Practices recommends updated COVID-19 and flu vaccines for everyone age 6 months and up.

Last year, some experts recommended waiting until the approach of an anticipated peak of respiratory infections in the winter, and getting the COVID shot in tandem with an influenza booster, Doron said. But recommendations may differ this year if COVID rates are still high when the new boosters arrive in the clinic.

Assoumou recommends any individual who has not received a booster in four months get the shot as soon as it becomes available.

Cases are high right now, she said. I feel like we all know somebody who had COVID or is recovering from COVID. So I think that given that theres a lot of virus circulating in the community, I would say as soon as it is available to get vaccinated.

The CDC recommends that everyone 6 months and older in the US, with rare exceptions, get a seasonal influenza vaccine. The shot is particularly important for people at high risk of developing flu-related complications, including adults 65 and older, children younger than 2 years of age, and individuals with certain chronic conditions.

But this year, older adults, pregnant women, and the parents of small children also have a new vaccination to consider.

After decades of research, vaccines protecting against respiratory syncytial virus, or RSV, made their debut last year. The highly contagious virus usually causes mild symptoms. But in some cases, it can lead to life-threatening pneumonia and dangerous lung swelling, causing between 60,000 and 120,000 hospitalizations and 6,000 to 10,000 deaths every year among adults 65 and older.

Federal officials have gone back and forth over who should get the one-time shot. Though approved for use by all adults 60 and older, evidence has emerged in recent months suggesting the vaccine may be linked to a heightened risk of a rare nervous system condition called Guillain-Barr syndrome . In its June meeting, a CDC advisory committee said more research and safety analysis is needed.

On Aug. 6, the CDC issued revised guidance, recommending individuals age 75 and older receive the new one-time vaccination. But it stopped short of recommending the shot for all seniors below the age of 75, instead highlighting 11 risk factors that place people age 60 to 74 at increased risk for severe disease due to RSV, including those with chronic heart, lung, or liver disease; severe obesity; certain types of diabetes; and who reside in a nursing home.

In the absence of those risk factors, a provider may still determine that a person in that age range is at high risk and should get the shot, the CDC said.

The CDC also suggests pregnant women and the parents of newborn babies protect themselves from the virus. It recommends either maternal RSV vaccination during weeks 32 through 36 of pregnancy, or infant immunization with RSV monoclonal antibodies. That advice applies to all infants age 8 months and younger, born during or entering their first RSV season, and to infants and children ages 8 to19 months who are at increased risk for severe RSV disease and entering their second RSV season.

Late summer and early fall are the best time to get vaccinated, the CDC says.

Adam Piore can be reached at adam.piore@globe.com.

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Heres what you need to know about fall booster shots for COVID-19, other respiratory illnesses - The Boston Globe

Vaccines for Children (VFC) Program 30 Years of Protecting Children | VitalSigns – CDC

August 16, 2024

Reaching more children: When the VFC legislation was passed 30 years ago, it was a historic step in improving the lives of children. Despite these successes, there is continued need to reach children who lack insurance and children in families with lower incomes. Healthcare providers that serve VFC-eligible children are critical to the VFC program, providing children easy access to vaccination services.

There are still opportunities to increase vaccination coverage (the proportion of children vaccinated) with all recommended vaccines for VFC-eligible children. Combined coverage for 7 selected vaccines (the combined 7-vaccine series) was just over 61% for VFC-eligible children born in 2020. For individual vaccines, uptake was highest (around 90%) for first doses of vaccines and vaccines given earlier in life. Coverage was lowest for vaccines that require multiple doses, with additional doses recommended after 12 months of age. This suggests VFC-eligible children face challenges to receiving vaccines that require multiple doses as well as in their second year of life.

Healthcare providers can help reduce missed opportunities for vaccination by giving multiple childhood vaccines at well-child visits. Robust communication efforts to reach parents of those eligible for the VFC program will help them be aware of, have confidence in, and able to access recommended vaccines for their children.

Insurance status: Vaccinations were lower among uninsured children than for children insured by Medicaid. This is consistent with data on vaccinations among uninsured adolescents and adults. Uninsured children are more likely to live below the poverty level and are less likely to have seen a healthcare provider in the past year. They are also less likely to complete vaccine series that require multiple doses. Efforts to connect children to health insurance can contribute to increased vaccinations.

Reaching low-income households: VFC-eligible children living below the poverty level had lower vaccination coverage for rotavirus vaccine and the combined 7-vaccine series compared with VFC-eligible children living at or above the poverty level. Although the VFC program provides vaccine at no cost, there may be fees for an office visit or non-vaccine services received during the visit. Healthcare costs beyond vaccination cost may be potential barriers for low-income households in addition to other barriers affecting access to vaccinations. Making sure all children have an established medical home increases the potential to be up to date with recommended vaccines.

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Vaccines for Children (VFC) Program 30 Years of Protecting Children | VitalSigns - CDC

Okinawa Air Force Clinic Says It Gave ‘Potentially Ineffective’ Childhood Vaccines as First Day of School Looms – Military.com

August 16, 2024

Officials at Kadena Air Base in Japan said that childhood vaccines administered at a clinic over nearly three months might be "potentially ineffective," with the news coming right as students on base are set to return to school.

The vaccinations were for measles, mumps and rubella, as well as varicella, a condition also known as chickenpox that is treated with the Varivax vaccine. The vaccines -- part of the recommended schedule of vaccinations for children -- were administered by the Kadena Immunization Clinic between May 3 and July 29.

"There are no assessed health risks associated with the administration of these vaccines," the Kadena Medical Clinic said on Facebook. "In the coming days, the 18th Medical Group immunizations staff will reach out to impacted patients to advise on corrective actions."

Read Next: The Army Sacks Another Senior Enlisted Leader in the Washington, DC, Area

First Lt. Robert Dabbs, a spokesman for the 18th Wing at Kadena Air Base, told Military.com that the issue arose from improper storage of the vaccines.

"The measles, mumps and rubella (MMR) and varicella (chickenpox/Varivax) vaccines were temporarily stored at colder than recommended temperatures," Dabbs said. "The 18th Wing is conducting a thorough investigation of this event to ensure the highest standards of safe, quality care for our community."

Dabbs declined to quantify the total number of individuals who were given the potentially ineffective vaccines.

During the investigation, the Kadena Medical Clinic announced on Facebook that the 18th Medical Group Immunization Clinic "will be closed during this process, and United States Naval Hospital Okinawa is available for urgent needs."

The naval hospital is also located on the island.

Both inoculations are required to attend Department of Defense Education Activity Schools, per public documents. The 2024-2025 school year for students attending Department of Defense schools in the Pacific is set to start next week, according to the online calendars.

Officials advised that people who have not been contacted by the 18th Medical Group clinic staff by Aug. 22 should call the 18th Medical Group Patient Advocate at "DSN 630-4146 or Comm 098-960-4146," according to the Facebook post.

This isn't the first time that the Kadena Medical Clinic has made errors when administering vaccines.

In January, the clinic announced on Facebook that staff had "determined that four pediatric patients were administered incorrect vaccines while receiving care."

Clinic staff contacted parents to check on children and address any questions or concerns, the base said at that time.

Related: Troops Suing Defense Department over Vaccine Mandate Reach $1.8 Million Settlement

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Okinawa Air Force Clinic Says It Gave 'Potentially Ineffective' Childhood Vaccines as First Day of School Looms - Military.com

Is there an mpox vaccine, and how does it work? – DW (English)

August 16, 2024

Have vaccines for mpox been developed? The short answer is yes, they have.

The European Union, United States, Canada and others approved the use of the MVA-BN vaccine back in 2022 during the first declared global health emergency formpox.

The long answer is a bit more complicated.

Vaccines to protect against an mpoxinfection do exist, but currently no available vaccines specifically target the monkeypox virus. How is this possible?

The monkeypox virus belongs to a genus of viruses called Orthopoxvirus, which are all complex DNA viruses.

Among others, viruses in this genus include the variola virus, which causes smallpox, the cowpox virus and the vaccinia virus.

Viruses from this genus have a great share of genetic similarity, which makes it possible for vaccines developed against other viruses to also be used to protect from mpox infection.

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Vaccines which protect against mpox rely ona phenomenon called cross-reactivity.

Cross-reactivity happens when different antigens different species of viruses, for example appear similar to our immune system.

Imagine this: As viruses from the Orthopoxvirus are structurally similar, if a person is infected by the variola virus, for example, the antibodiesthat their cells willproduce against the viruswill also be able to protect them against a monkeypox virus infection.

Cross-reactivity between antibodies to Orthopoxvirus allows a vaccine developed to fight smallpox, for example, to also work with mpox infections.

The answer currently seems to be:there is no guarantee.

Smallpox was declared eradicated in 1980 after a decadeslong global mass vaccination effort.

After the 1980s, mass immunization against the disease stopped, which some researchers suggest could have increased the susceptibility of people to other forms ofOrthopoxvirus, including the monkeypox virus.

In fact, people born after the end of the universal smallpox vaccination program have lower levels of antibodies against the monkeypox virus.

This could explain why men aged 18-44 accounted for the majority of cases in the previous 2022-2023 mpox global outbreak.

But previous smallpox vaccination doesnt mean that a person is fully protected from contracting mpox.

Previous studies have suggested that the smallpox vaccine is about 85% effective in preventing monkeypox virus infection, but people who have received a smallpox vaccine seem to have milder cases of mpox .

As of August 2024, there is only one vaccine approved for use against mpox across all of the EU/EEA, United Kingdom, United States, Switzerland and Canada.

This is the MVA-BN vaccine, also known as Modified Vaccinia Ankara-Bavarian Nordic.

The vaccine consists of a weakened strain of the vaccinia virus one of the viruses from the Orthopoxvirus genus, which the monkeypox virus belongs to.

The Modified Vaccinia Ankaravaccine was developed in the 1950s and '60s in Germany and was originally used to protect against smallpox infection.

Its current form, MVA-BN, was developed by the Danish biotech company Bavarian Nordic and has been in production since 2010. It is given in two doses, usually 28 days apart.

TheWorld Health Organizationlists another two vaccines approved bydifferent regulatory agencies for the prevention of mpox.

During the 2022 mpox outbreak, Japan approved the smallpox vaccine LC16, and Russia licensed OrthopoxVac for immunization against smallpox, mpox and other orthopoxviruses.

In the United States and Australia, ACAM2000, a vaccine which contains a live vaccinia virus, is recommended for people at risk for exposure to Orthopoxvirus infections.

Yes. One example is a new mRNA vaccine BNT166 specifically targeting antigens on the monkeypox virus, which is now under clinical evaluation.

You might be familiar with mRNA vaccines from the COVID-19 pandemic and the ensuing global vaccination effort.

Currently, the WHO doesn't recommend a mass vaccination program. It recommends that only people who are at risk or who have been in contact with the virus should be considered for vaccination.

Edited by: Martin Kuebler

Sources and data:

Li D, Wang H, Sun L, et al. Levels of antibodies against the monkeypox virus compared by HIV status and historical smallpox vaccinations: a serological study. Emerging Microbes & Infections. Published in2024. https://doi.org/10.1080/22221751.2024.2356153

Zuiani A, Dulberger CL, Silva, et al. A multivalent mRNA monkeypox virus vaccine (BNT166) protects mice and macaques from orthopoxvirus disease. Cell.Published in 2024. https://doi.org/10.1016/j.cell.2024.01.017

Jezek Z, Grab B, Szczeniowski M, Paluku K, Mutombo M. Human monkeypox: secondary attack rates. Bulletin of the World Health Organization. Published in 1988. https://pubmed.ncbi.nlm.nih.gov/2844429/

Marzuki C, Zaid A, Azman FW, et al. Vaccines for Orthopoxviruses: A Review. Malaysian Journal of Medicine and Health Sciences. Published in2023. https://doi.org/10.47836/mjmhs.19.s9.41

CDC. Mpox in the US. Centers for Disease Control and Prevention. Published October 19, 2022. https://www.cdc.gov/poxvirus/mpox/clinicians/vaccines/vaccine-considerations.html

Akter F, Tahira Binte Hasan, Alam F, et al. Effect of prior immunisation with smallpox vaccine for protection against human Mpox: A systematic review. Reviews in Medical Virology. Published in 2023. https://doi.org/10.1002/rmv.2444

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Is there an mpox vaccine, and how does it work? - DW (English)

COVID is on the rise this summer. Here’s why and what else you should know – NPR

August 16, 2024

A Health Care Worker seals a coronavirus swab after testing at the Pro Health Urgent Care coronavirus testing site on April 30, 2020 in Wantagh, New York. Al Bello/Getty Images North America hide caption

If it seems like a lot of people are getting COVID right now, youre not imagining it.

Were in the middle of a worldwide summer COVID-19 wave.

A high or very high level of COVID-19 virus is being detected in wastewater in almost every state, according to data from the Centers for Disease Control and Prevention. At least 10 other states have a high amount of COVID in the wastewater.

Were now relying on wastewater data, because people arent testing. We cant have other reliable measures, said Dr. Ashish Jha, dean of the School of Public Health at Brown University and former White House COVID-19 response coordinator in an interview with NPRs Morning Edition. He said that based on the wastewater data, this is turning out to be possibly the biggest summer wave weve had.

Jha said weve settled into what feels like a more familiar pattern with COVID. Recently, the CDC labeled COVID as being endemic, meaning that COVID is here to stay in predictable ways.

There are two waves a year: one during summer and another during winter. The summer wave tends to be a little smaller, while the winter wave is bigger. But unlike the flu, which has a wave in the winter and almost no cases after, COVID infections can rise in between waves.

Its looking like this is probably not a seasonal virus, so it will likely be year round, said Dr. Otto Yang, associate chief of infectious diseases and UCLA and professor of medicine in an interview with Morning Edition.

Jha adds that the summer wave this year is still smaller than any of the winter ones, but as far as summer waves go, this has been a substantial one. It started a little earlier than the one last summer, and infections are still rising. Jha is hopeful that the surge will peak and ease soon, but he doesnt know exactly when that will happen.

COVID is continuing to evolve very rapidly, and every three or four months we get a new COVID variant. This summer, the dominant strains of COVID are KP.3.1.1, accounting for 27.8% of U.S cases and KP.3, accounting for 20.1%, according to data from the CDC and the Infectious Diseases Society of America. Jha said that these variants evolved from Omicron.

It doesnt seem like these variants are more deadly. But they are almost certainly more contagious, said Yang. So if you have something thats equally deadly but more contagious, you will see more severe illnesses and deaths.

A new vaccine is currently being developed to target these new dominant variants. It is expected to come out in September.

Theyre better matched to their variants. The antibodies should work better. And so they would hopefully reduce the number of people that are getting symptomatic COVID and hopefully with that reduce the circulation, said Yang. Like the current vaccines, Yang expects the new vaccine to work well to prevent severe illness and death.

Jha echoed that the new vaccines will be very protective against the current variants. He said the vaccines available right now are targeted to the variants that were dominant last year, and those are long gone. The COVID vaccines are not going to provide a lot of protection against infection, if any at all. But they would still provide some protection against serious illness, he said.

If you havent gotten your vaccine this year, Jha recommends waiting until the new vaccine comes out in a few weeks for the best protection.

He acknowledges that asking people to make substantial changes to their lives four and a half years into the virus is a tall order. For most people, he said, getting vaccinated is good enough. And if you are high risk and do get infected, treatments like Paxlovid are a great option, he added.

Jha said that the recommendation for most people is to get one shot a year, He said theres evidence that for the highest risk people, like elderly people in their late 70s or 80s or people who are immunocompromised, a second shot in the spring can offer an important level of protection. And for most Americans, they should focus on getting one shot a year.

What I recommend to people is they get it around the time they get their flu shot, which is usually in late September or October, said Jha.

Yang, though, thinks it is a good idea for anyone to get a booster if they havent had a COVID vaccine in six months.

Even though Jha said this may be the worst summer COVID spike weve had, he said there is some good news.

If you look at deaths from COVID so far in 2024, its down pretty substantially from 2023. So yes, were getting these surges but theyre not turning into hospitalizations and deaths at the same kind of numbers weve seen in past years, Jha said. Thats progress. Thats good news. That is immunity being built up over time. And so each infection just doesnt mean as much as it did four years ago, or even as much as it did two years ago.

This article was edited by Obed Manuel.

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COVID is on the rise this summer. Here's why and what else you should know - NPR

Pfizer Reports Positive Phase 3 Results for RSV Vaccine in Immunocompromised Adults – AJMC.com Managed Markets Network

August 16, 2024

Pfizer announced encouraging top-line results from substudy B of its pivotal Phase 3 MONeT trial, demonstrating that the respiratory syncytial virus (RSV) vaccine Abrysvo is both well-tolerated and effective in generating strong neutralizing responses in immunocompromised adults aged 18 and older.1

The RSV vaccine showed strong immunogenicity and safety in immunocompromised adults, study finds. | Image credit: jetcityimage - stock.adobe.com

Immunocompromised adults, such as patients with cancer or autoimmune disorders, have a substantially increased risk of experiencing severe complications from RSV, yet there are currently no vaccines approved for those aged 18 to 59 in the US, said Annaliesa Anderson, PhD, senior vice president and chief scientific officer of Vaccine Research and Development, Pfizer, in a statement. We are encouraged by the positive top-line data from this study, which provide important evidence that Abrysvo has the potential to address a significant unmet need in this vulnerable population.

RSV is a common respiratory virus that usually causes symptoms resembling a cold.2 Currently, the CDC recommends an RSV vaccine for everyone aged 75 and older and for adults aged 60 to 74 who are at increased risk of severe RSV.

The study (NCT05842967) included individuals with conditions such as non-small cell lung cancer (NSCLC), end-stage renal disease, autoimmune disorders, and solid organ transplants.1 Approximately 203 immunocompromised adults were enrolled in the study, of which approximately half were aged 18 to 59, and the other half were aged 60 years and older.

Participants received 2 doses of the vaccine, administered 1 month apart. The primary end point was to assess the safety of the vaccine, including any adverse events or reactions. The secondary end point was to evaluate the immunogenicity of the vaccine, specifically measuring the neutralizing antibody response against both RSV-A and RSV-B subtypes.

Safety data were collected throughout the trial, while immunogenicity was assessed by measuring levels of neutralizing antibodies in blood samples taken before and after vaccination.

The vaccine demonstrated a consistent safety profile, with no unexpected adverse effects reported across the diverse participant groups, including those with NSCLC, individuals on hemodialysis due to end-stage renal disease, those with autoimmune inflammatory disorders receiving active immunomodulator therapy, and solid organ transplant recipients.

While the study evaluated doses of the vaccine, the findings indicated that a single dose was sufficient to elicit a strong neutralizing response against both RSV-A and RSV-B subtypes, exhibiting robust immune protection.

Furthermore, Pfizer plans to present these results at an upcoming scientific conference and to submit the data for review by regulatory agencies, which could lead to the approval and availability of the vaccine for immunocompromised adults. Pfizer has also initiated a clinical trial evaluating the vaccine in children aged 2 to 18 years who are at increased risk for RSV.

Many health care providers and pharmacies prefer the simplicity of having 1 vaccine for both adult vaccinations and maternal vaccination, which only Abrysvo can offer, Pfizers chief US commercial officer, Aamir Malik, said on a call to Fierce Pharma.3 As for the limited Advisory Committee on Immunization Practices (ACIP) policy, Malik said the guidance offers clarity and strengthens the directive for those who are eligible for a vaccine.

According to the statement, these results contribute to the growing body of evidence supporting the vaccine as an effective and safe option for preventing RSV-related illnesses in high-risk populations, including those with compromised immune systems.1

References

1. Pfizer announces top-line results of Abrysvo for RSV in immunocompromised adults. News release. Pfizer. Published August 2, 2024. Accessed August 15, 2024. https://www.businesswire.com/news/home/20240812622927/en/Pfizer-Announces-Top-Line-Results-of-ABRYSVO%C2%AE-for-RSV-in-Immunocompromised-Adults

2. RSV (respiratory syncytial virus) immunizations. CDC. Published July 3, 2024. Accessed August 15, 2024. https://www.cdc.gov/vaccines/vpd/rsv/index.html

3. Pfizer, looking to expand RSV vaccine's reach, touts its benefits in immunocompromised adults. Fierce Pharma. Published August 12, 2024. Accessed August 15, 2024. https://www.fiercepharma.com/pharma/pfizer-looks-expand-abryxvos-reach-rsv-vaccine-shows-benefit-immunocompromised-adults

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