Category: Vaccine

Ohio's 6-week abortion ban has forced women with cancer to seek out-of-state abortions so they can receive cancer treatment. In at least two cases, women were refused cancer treatment until they had abortions. (The 19th)

CT and MRI may miss some pancreatic tumors, reducing the potential for early detection and a chance at life-saving surgery, according to a study presented at United European Gastroenterology (UEG) Week 2022 in Vienna.

An oncologist reflects on being on "the other side" of grief. (JCO Art of Oncology)

Merck and Moderna announced a collaboration to develop a personalized cancer vaccine. The mRNA vaccine is currently being tested in combination with pembrolizumab (Keytruda) among patients with high-risk melanoma in a phase II trial.

Data from worldwide cancer registries suggest the emergence of a global epidemic of cancers in younger adults. (CNN)

Patients with inflammatory breast cancer, and particularly triple-negative breast cancer, face an increased risk for developing central nervous system metastases. (Cancer)

A phase II study of neoadjuvant atezolizumab (Tecentriq) for resectable non-small cell lung cancer showed a 20% rate of major pathologic response. (Journal of Thoracic and Cardiovascular Surgery)

Data on 33,000 patients with breast cancer provided new insights into the distinct clinical features of invasive lobular cancer versus invasive ductal cancer, further emphasizing the need for different types of management. (Journal of the National Cancer Institute)

Disparities in cancer mortality stratified by education level widened during the height of the COVID-19 pandemic. (American Journal of Preventive Medicine)

Using electronic health records to glean information about patient-reported outcomes was associated with significant improvement in clinical outcomes. (Journal of Clinical Oncology)

Charles Bankhead is senior editor for oncology and also covers urology, dermatology, and ophthalmology. He joined MedPage Today in 2007. Follow

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Abortion Bans and Cancer Care; Melanoma Vaccine in the Works; New Cancer Epidemic? - Medpage Today

COVID-19 vaccination, booster shots and prior infection all were associated with a significant reduction in the risk of infection, hospitalization and death from SARS-CoV-2, including the Omicron variant, but the protection waned over time, a recent study confirmed.

The cohort study, published in JAMA, included 10.6 million residents in North Carolina from March 2, 2020, through June 3, 2022. During that time, 2,771,364 SARS-CoV-2 infections were reported to the North Carolina COVID-19 surveillance system, with a hospitalization rate of 6.3% and a 1.4% mortality rate.

Receipt of primary COVID-19 vaccine series compared with being unvaccinated, receipt of boosters compared with primary vaccination, and prior infection compared with no prior infection were all significantly associated with lower risk of SARS-CoV-2 infection (including Omicron) and resulting hospitalization and death, the study authors, led by Danyu Lin, PhD, of the Gillings School of Global Public Health at the University of North Carolina, wrote. The associated protection waned over time, especially against infection.

About two-thirds of the study participants had been vaccinated by June 3. The average age was 39, 51.3% were female, 71.5% were White, 9.9% were Hispanic.

Primary vaccination with the Pfizer-BioNTech vaccine was associated with a 54.3% estimated effectiveness against infection, 85.8% against hospitalization and 89.6% against death at seven months after the first dose. At 12 months, estimated effectiveness against infection, hospitalization and death dropped to 37.5%, 58.8% and 75.2% respectively.

For the Moderna vaccine, the estimated effectiveness at seven months after the first dose was 69.2% against infection, 89.8% against hospitalization and 93% against death, dropping to 47.2%, 64.7% and 69.6% respectively at 12 months.

For the Johnson & Johnson vaccine, the estimated effectiveness at seven months was 60.2% against infection, 69.7% against hospitalization and 76.7% against death, dropping to 50.7%, 56.3% and 73.6% respectively at 12 months.

The immunity conferred by boosters against infection waned rapidly after 4-6 months, Lin told Contagion. The immunity conferred by infection with the Omicron variant against reinfection with omicron also waned faster than expected.

After boosters, estimated effectiveness peaked at around two to four weeks before declining.

For Pfizer/BioNTech boosters taken in December 2021, estimated effectiveness was 61.2% after one month, dropping 16.2% after three months. For Moderna boosters following Pfizer primary series, estimated effectiveness was 68.4% at one month, dropping to 40.5% at three months. For Moderna boosters following Moderna primary series, those numbers were 62.1% and 14.7%. For Pfizer boosters following Moderna primary series, they were 66.1% and 27%

Vaccination and boosting are beneficial, especially against hospitalization and death, Lin said.

Prior infection was associated with an 86.5% estimated effectiveness against reinfection, 96.2% against hospitalization and 94.5% agasint death after four months, dropping to 75.8%, 95.2% and 94.4% after eight months and 62.2%, 91% and 89.5% after 12 months.

This study reinforced the growing complexities of COVID-19 and the strengths and limitations of routine surveillance systems, Mark Tenforde, MD, PhD; Ruth Link-Gelles, PhD; and Manish Patel, MD, with the CDC COVID-19 Response Team, wrote in an editorial comment. State-based surveillance systems have large sample sizes that allow detection of uncommon events and multiple subgroup analyses. However, they often lack granular details on underlying medical conditions or other factors that allow for better control of confounding or effect modification.

They noted that emerging variants, including Omicron were associated with lower effectiveness against infection, but pointed out that even modest protection may reduce surges and the consequences of them.

Next steps include research to determine the effectiveness of second boosters, effectiveness of bivalent boosters and effectiveness of vaccines in children younger than 5 years.

See the article here:

COVID-19 Vaccines, Boosters and Prior Infection Significantly Reduce Risks - Contagionlive.com

Did a recent study show that women are harming their babies by breastfeeding after getting mRNA COVID-19 vaccines?

Thats what a claim circulating on Instagram and Facebook feeds suggested.

"7 out of 11 women had mRNA in their breast milk," read an image of a tweet shared on Instagram. "This isnt just a disaster for infants, its more proof that mRNA/LNP in the shots hits practically every cell in the body."

The tweet was written by Alex Berenson, a former New York Times reporter who has shared misleading claims about COVID-19 vaccines. It included a retweet from the Twitter account for the medical journal JAMA promoting the Sept. 22 publication of a study that examined the presence of trace amounts of mRNA vaccines in lactating womens breast milk.

Contrary to Berensons assertion, however, the study did not suggest this amounts to disastrous news for infants. It said results suggested breastfeeding post-vaccination is safe and that more research is needed.

The post was flagged as part of Instagrams efforts to combat false news and misinformation on its News Feed. (Read more about our partnership with Meta, which owns Facebook and Instagram.)

The study, conducted by researchers from New York Universitys Long Island School of Medicine, involved the collection of breast milk samples from 11 women whod received Pfizer/BioNTech or Moderna COVID-19 vaccines within 6 months after childbirth. The participants were asked to collect samples before being vaccinated and for five days after being vaccinated.

"Of 11 lactating individuals enrolled, trace amounts of BNT162b2 and mRNA-1273 COVID-19 mRNA vaccines were detected in seven samples from five different participants at various times up to 45 hours post-vaccination," part of the studys results read.

This discovery did not raise alarms for the researchers.

"The sporadic presence and trace quantities of COVID-19 vaccine mRNA detected in EBM (evidence-based medicine) suggest that breastfeeding after COVID-19 mRNA vaccination is safe, particularly beyond 48 hours after vaccination," they said.

The researchers did not test the cumulative effects of that exposure to trace mRNA on the infants and wrote that more research is needed. They also wrote that "caution is warranted about breastfeeding children younger than 6 months in the first 48 hours after maternal vaccination until more safety studies are conducted."

COVID-19 vaccines are not currently recommended for infants younger than 6 months old. But the Centers for Disease Control and Prevention, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine recommend that "everyone should receive the COVID-19 vaccine, including those who are pregnant or breastfeeding."

Dr. Nazeeh Hanna, the studys lead author and chief of NYU Langone Hospital-Long Islands neonatology unit told PolitiFact that although much of the data is still lacking, theres no evidence to suggest that any amount of either vaccine is harmful to infants who are breastfeeding.

BeyondmRNA vaccines, the FDA has authorized or approved COVID-19 vaccines that do not rely on mRNA technology. These include the Janssen/Johnson & Johnson vaccine and the Novavax vaccine.

Our ruling

An Instagram post suggested that a new study from JAMA showed that traces of mRNA COVID-19 vaccines found in breast milk for seven of 11 mothers are harmful for nursing newborns.

A study involving 11 lactating mothers who had been vaccinated found that samples from five of them contained trace amounts of mRNA COVID-19 vaccines up to 48 hours after vaccination. But researchers said the findings suggested vaccination was safe. They said that until further study is done, women should use caution when breastfeeding infants younger than 6 months in the 48 hours after getting vaccinated.

We rate this claim Mostly False.

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A small study of breastmilk and mRNA vaccines did not show babies are being harmed - PolitiFact

October 12, 2022

Media Contact:

Chase Cook, Acting Director of Communications, 410-767-8649

Maryland Primary Care Vaccine Program surpasses 500,000 COVID shots administered

COVID-19 primary vaccines and booster shots now available at more than 500 adult and family primary care practices across Maryland

Baltimore, MD More than 500,000 Marylanders have received their COVID-19 primary vaccines and booster shots from their family doctors via the Maryland Department of Healths (MDH) Maryland Primary Care Programs (MDPCP) Vaccine Program. The MDPCP, which was launched in March, 2019, is engaged with more than 500 primary care practices across the state to encourage the more than four million Marylanders they serve to be COVIDReady by staying up to date with their COVID-19 vaccines and boosters.

The MDPCP is ensuring Marylanders have easy access to COVID-19 vaccines when at their trusted doctors office during visits for other health services, like their annual flu shot.

Clinical providers statewide continue to play a critical role in helping keep Marylanders COVIDReady by protecting them against severe illness and hospitalization with COVID-19 vaccines, including the new bivalent booster shots, said Dr. Howard Haft, Senior Medical Advisor of the MDPCP. MDH has worked closely with our invaluable health care providers statewide to facilitate convenient and equitable access to life-saving COVID shots. Talk with your provider today to make sure you and your family are up to date with your COVID-19 vaccines.

COVID-19 bivalent boosters are available to Marylanders age 12 and above who have received their last primary COVID vaccine or booster at least two months ago. The bivalent booster has been modified to help protect against both original COVID-19 and its Omicron variants.

The Are You Up-To-Date? portal allows you to check your vaccination status within seconds. Find a vaccination clinic near you.

Throughout the COVID-19 pandemic, the MDPCP has supported primary care practices in their response efforts by providing access to essential resources, such as free personal protective equipment and point-of-care rapid tests. The MDPCP was established in 2019 to support advanced primary care delivery, improve health outcomes and control total healthcare spending growth, and includes more than 500 practices statewide serving more than four million Marylanders.

For more information about COVID-19 in Maryland, visit covidLINK.maryland.gov. For the most recent Maryland COVID-19 data, visit coronavirus.maryland.gov.

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The Maryland Department of Health is dedicated to protecting and improving the health and safety of all Marylanders through disease prevention, access to care, quality management and community engagement.

Follow us at http://www.twitter.com/MDHealthDept and at Facebook.com/MDHealthDept

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Pages - Maryland Department of Health

Flu season is officially upon us, and County Executive George Latimer and Health Commissioner Dr. Sherlita Amler are encouraging residents to get vaccinated to remain healthy and safe.

The Westchester County Health Department will offer both the flu vaccine and COVID-19 bivalent booster by appointment. every Monday and Friday in October from 10 a.m. to 3 p.m., at 134 Court Street in White Plains.

Latimer said: As we have seen since over the past two years, COVID-19 infection rates tend to rise during the fall and winter months, and the same goes for transmission of the flu. We should all be taking careful precautions to prevent the spread of COVID and the flu, and getting your vaccines will help us do that. It is strongly recommended to get both the bivalent COVID booster and the flu shot at the same time, to better protect yourself from both illnesses.

Health Commissioner Sherlita Amler, MD, said: Combining vaccines is safe, and it is much more convenient to schedule both at the same time. Children often receive multiple shots at once, and you are much less likely to skip a vaccine if both are given together. Vaccines for flu and COVID-19 offer the best protection we have to fight these diseases, so the sooner you get vaccinated, the better.

Go to the Westchester County Health website to book your vaccine visit. Flu shots are available for anyone age three and older, and high-dose flu vaccine is available for people ages 65 and older. Children may receive a COVID-19 vaccine at the same time as they get a flu shot on Friday mornings this month. Bivalent COVID-19 boosters are available for adults and children ages 12 and up who received their most recent COVID-19 vaccine at least two months ago.

Additional Health Department Flu and COVID Bivalent Booster vaccine clinics are as follows:

Thursday, Oct. 20, 20222 to 6:30 p.m.Yonkers Riverfront LibraryMain Entrance Atrium and Childrens Library on Second Floor1 Larkin Center, Yonkers, NY 10701

Friday, Oct. 28, 20229 a.m. to 1 p.m.Don Bosco Community Center22 Don Bosco Place, Port Chester, NY 10573

Thursday, Nov. 3, 20222 to 6:30 p.m.Yonkers Riverfront LibraryMain Entrance Atrium and Childrens Library on Second Floor1 Larkin Center, Yonkers, NY 10701

For more information, visit the Health Department Website.

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Westchester County Promotes Flu Vaccine and COVID Bivalent Booster with upcoming Health Department Clinics - Westchester County Government

A study in Japan finds antibody response to the Moderna COVID-19 mRNA vaccine does not vary depending on the time of day when the dose was received.

Many physiological and behavioral functions including the immune system exhibit circadian rhythms. Several studies have investigated if the immune response to COVID-19 vaccines varies depending on the time of day when the dose was received, but results were dependent on type of vaccine, participants' age and sex. Now, a study conducted by scientists at Hokkaido University and colleagues in Japan has found no association between antibody response to COVID-19 vaccine and time of day of vaccination. They do add to the body of literature that could ultimately guide vaccination optimization. The findings were published in the Journal of Biological Rhythms.

The researchers recruited their study participants from Hokkaido University employees and students who received their first dose of the mRNA-1273 (Moderna) vaccine two to four weeks earlier. Those who had been previously infected with COVID-19 were excluded. The study group did not include shift workers, a crucial difference between this and some previous studies on healthcare workers.

The team collected demographic data on the final group of 332 Japanese participants and took blood samples to measure antibody titers against SARS-CoV-2. They then conducted statistical analyses to find out if there were associations between the time of day when the participants received their vaccine dose, any of the demographic characteristics, and the immune response.

"Our analyses revealed no significant association between the time of day of vaccination and the SARS-CoV-2 antibody concentration, but we did find that antibody titers decreased in participants aged 50 to 64, which is consistent with previous studies," says Hokkaido University physiologist Dr. Yujiro Yamanaka, who specializes in studying chronobiology.

Conflicting results between studies could be explained by various factors, including differences in sex, age, physical activity, and natural immune system, the type of vaccine received, number of days after vaccination, and differences in vaccine dose. Scientists also need to more fully understand whether other factors like race play a role.

The limitations reduce our ability to conclusively rule out the possibility that circadian rhythms influence antibody response to vaccination. Larger randomized studies are needed to more conclusively guide vaccination strategies regarding a time-of-day variable."

Dr. Yujiro Yamanaka, Physiologist, Hokkaido University

Source:

Journal reference:

Yamanaka, Y.,et al.(2022) Time of Day of Vaccination Does Not Associate With SARSCoV2 Antibody Titer Following First Dose of mRNA COVID19 Vaccine. Journal of Biological Rhythms.doi.org/10.1177/07487304221124661.

Link:

Antibody response to COVID-19 vaccine not associated with time of day of vaccination - News-Medical.Net

BRUSSELSDuring a hearing today on the European Unions COVID-19 response, Pfizers president of international developed markets, Janine Small, admitted that its vaccine had never been tested before its release to the general public on its ability to prevent the transmission of COVID when asked by Dutch politician and a currentMember of the European Parliament(MEP) Robert Rob Roos.

Regarding the question around did we know about stopping immunization before it entered the marketNo., Small replied with a smirk when asked by Roos if the Pfizer COVID vaccine was ever tested to stop the transmission of the virus before it entered the market.

She continued, We have to really move at the speed of science to really understand what is taking place in the market.

It was not clear from the questioning of Ms. Small if she were referring to the Pfizer BioNTech (BNT162b2) vaccine which is authorized under Emergency Use Authorization or Comirnaty which is the FDA-approved vaccine. Under an Emergency Use Authorization, vaccines cannot be mandated.

According to the August 2022 article, The Pfizer BioNTech (BNT162b2) COVID-19 vaccine: What you need to know, it states that there is modest vaccine impact on transmission to prevent COVID infection.

In response to the COVID-19 pandemic, the EU implemented a wide range of health policies with its EU Vaccines Strategy and initiatives, one being EU Digital COVID Certificates which exempted persons from free movement restrictions. The EU implemented free movement restrictions to slow down the spread of coronavirus and protect the health and well-being of all Europeans.

EU Parliamentarian Roos, exposed an alleged misinformation campaign by Pfizer with the release of his video tweet today. In it he called the actions criminal, scandalous and a cheap lie.

Below is a transcript of Roos Twitter post:

If you dont get vaccinated, youre antisocial. This is what the Dutch prime minister and health minister told us. You dont get vaccinated just for yourself, but also for others. You do it for all of society, thats what they said. Today, this turned out to be complete nonsense.

In a COVID hearing in the European Parliament, one of the Pfizer directors just admitted to me at the time of introduction, the vaccine had never been tested on stopping the transmission of the virus.

This removes the entire legal basis for the COVID Passport. The COVID passport that led to massive institutional discrimination as people lost access to essential parts of society. I find this to be shocking, even criminal.

This is scandalous. Millions of people worldwide felt forced to get vaccinated because of the myth that you do it for others. Now this turned out to be a cheap lie.

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Bombshell: Pfizer Exec admits COVID vaccine never tested on preventing transmissions - Lynnwood Times

Most vulnerable protected against COVID-19 and flu.

Over a million vaccines have been delivered to protect against the latest strains of flu and COVID-19 in the latest efforts to relieve pressure on the NHS over winter.

Frontline healthcare staff and the countrys most vulnerable have been immunised at speed with 80.2% of all care home residents being fully vaccinated since the rollout began in September.

The next groups in line for their vaccines over 65s and those at high-risk are receiving a scheduled appointment and 50-64 year olds will soon be invited to book an appointment. Anyone who has missed an appointment can reschedule through the NHS Inform online booking portal.

The COVID-19 vaccine is being given at the same time as the flu jab where possible, and so far 94% of those invited have had both at the same appointment. Over two million Scots will be offered both vaccines over the next three months a pace that aims to maintain Scotlands place as a leading nation on vaccine uptake.

Health Secretary Humza Yousaf said:

This impressive uptake is testament to the frontline staff who got us through the pandemic and continue to protect our population and NHS from the threats that winter brings.

Scotland remains steadfast in the effort to protect everyone continuing the huge success of the vaccination programme since it was first rolled out in December 2020.

COVID-19 has not gone away and I call on everyone to take up the offer of a booster as soon as their invitation arrives to protect themselves, their families and the NHS.

BACKGROUND

1,369,270 COVID-19 and flu vaccines have been delivered since the winter vaccine programme launched.

Both new bivalent vaccines, which target Omicron and the original variant of COVID-19, are being deployed alongside existing vaccines, though the vaccination individuals receive will depend on age and vaccine availability. Both the current and new bivalent vaccines provide good protection from severe illness and hospitalisation from known COVID-19 variants.

Rearrange or opt-out of your vaccination appointment | NHS inform

Winter vaccines | NHS inform

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More than 1.3 million winter vaccines delivered - gov.scot - The Scottish Government

Contributors: KA, JPR, and DS contributed equally to this work as lead author. WHS and MWT contributed equally to this work as senior author. Guarantors of this work include WHS (protocol and data integrity), KA (statistical analysis), ASL (viral sequencing laboratory methods), JDChappell (reverse transcription polymerase chain reaction laboratory methods), and NJT (antibody measurement methods). WHS was responsible for the decision to submit the manuscript, KA, JPR, DS, MWT, and WHS drafted the initial manuscript (without outside assistance). KA, JPR, DS, MG, AAG, TM, SG, BH, KT, JDCasey, NM, AZ, NIS, KWG, DCF, MH, DNH, HA, MP, AEF, MCE, MG, AM, NJJ, VS, JSS, IDP, SMB, ETM, AM, ASL, AK, CLH, LWB, CtL, AD, JGW, AJG, NQ, SYC, CM, CR, HB, JHK, JDChappell, NH, CGG, TR, WBS, AB, CJL, KH, SNL, NJT, SP, MLM, MMP, MWT, and WHS conceptualized the study methods. KA, MWT, CJL, KH, and YZ were responsible for statistical analysis and data management. WHS acquired funding. KA, JPR, DS, MG, AAG, TM, SG, DH, HKT, JDCasey, NM, AZ, NIS, KWG, DCF, MH, DNH, HA, MP, AEF, MCE, MG, AM, NJJ, VS, JSS, IDP, SMB, ETM, AM, ASL, AK, CLH, LWB, CtL, AD, JGW, AJG, NQ, SYC, CM, CR, HB, JHK, JDChappell, NH, CG, TR, WBS, AB, CJL, KH, SNL, NJT, SP, MLM, MMP, MWT, and WHS critically reviewed the manuscript for important intellectual content. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

Competing interests: All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/coi_disclosure.pdf and declare: Funding for this work was provided to all participating sites by the US Centers for Disease Control and Prevention. SMB reports grants from the National Institutes of Health (NIH) and Department of Defense (DoD), participation as the Data Safety Monitoring Board (DSMB) chair for Hamilton Ventilators, and participation as a member of the DSMB for New York University covid-19 clinical trials. JDCasey reports funding from NIH and DoD. SYC reports consulting fees from La Jolla Pharmaceuticals, PureTech Health, and Kiniska Pharmaceuticals, payments or honorariums from La Jolla Pharmaceuticals, and participation on a DSMB for an investigator initiated study conducted at UCLA. JDChappell reports grants and other support from NIH. AD reports consulting fees from ALung technologies. MCE reports payments or honorariums from Abbott Laboratory for sponsored talks. DCF reports consulting fees from Cytovale and participation on a DSMB for Medpace. AEF reports grants from NIH. MG reports grants from CDC, CDC-Abt Associates, CDC-Westat, and Janssen, and a leadership role as co-chair of the Infectious Disease and Immunization Committee of the Texas Pediatric Society, Texas Chapter of American Academy of Pediatrics. KWG reports funding from NIH/National Heart, Lung, and Blood Institute (NHLBI) for the ACTIV-4HT NECTAR trial. AAG reports grants from NIH, DoD, AbbVie, and Faron Pharmaceuticals. MG reports grants from NIH/NHLBI and Agency for Healthcare Research and Quality (AHRQ), consulting fees from Endpoint, a leadership role on the American Thoracic Society (ATS) executive committee and board as well as support from ATS for meeting travel expenses, and participation on a DSMB for Regeneron. CG reports grants from NIH, CDC, Food and Drug Administration, AHRQ, Sanofi, and Syneos Health and consulting fees from Pfizer, Merck, and Sanofi. DNH reports grants from NIH/NHLBI for the ACTIV-4HT NECTAR trial and Incyte and participation as a DSMB chair for the SAFE EVICT Trial of vitamin C in COVID-19. NH reports grants from NIH, Quidel, and Sanofi and honorariums for speaking at the American Academy of Pediatrics (AAP) conference. CLH reports grants from NIH and American Lung Association (ALA) and participation as a DSMB member for iSPY COVID and Team (ANZICS). NJJ reports grants from NIH/NHLBI/NINDS and the University of Washington Royalty Research Fund and payment for expert testimony for the Washington Department of Health. AK reports grants from United Therapeutics, Gilead Sciences, and 4D Medical and a leadership role on the guidelines committee for Chest. JHK reports grants from NIH/NIAID. ASL reports grants from CDC, NIH/NIAID, and Burroughs Wellcome Fund and consulting fees from Sanofi and Roche. CJL reports grants from NIH, DoD, CDC, bioMerieux, Entegrion, Endpoint Health, and AbbVie, patents for risk stratification in sepsis and septic shock, participation on DSMBs for clinical trials unrelated to the current work, a leadership role on the executive committee for the Board of Directors of the Association for Clinical and Translational Science, and stock options in Bioscape Digita. ETM reports grants from Merck, CDC, and NIH and payment/honorariums from the Michigan Infectious Disease Society. TM reports payment/honorariums from the Society of Hospital Medicine. AM reports grants from CDC and NIAID/NIH and participation on a DSMB for the FDA. IDP reports grants from NIH, Janssen, Regeneron, and Asahi Kasei Pharma. TR reports grants from AbbVie, consulting fees from Cumberland Pharmaceuticals, and Cytovale, membership on a DSMB for Sanofi, a leadership role as immediate past president of the American Society of Parenteral and Enteral Nutrition, and stock options in Cumberland Pharmaceuticals. WHS reports receiving the primary funding for this project from the CDC, and research funding from Merck and Gilead Sciences. WBS reports grants from the NIH/NHLBI.

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Vaccine effectiveness of primary series and booster doses against covid-19 associated hospital admissions in the United States: living test negative...

One child dies every two minutes from malaria. Wider use of a new vaccine can make a dent in that devastating statistic.

The World Health Organization recommends the vaccine for broad use in sub-Saharan Africa and other areas with moderate to high malaria transmission, after years of studies in some 900,000 children showed it to be safe and effective.

But despite this widely hailed breakthrough, the malaria vaccine hasnt been met with the enthusiasm we think it deserves. Some big players, like the Bill and Melinda Gates Foundation and the Global Fund donors we admire and partner with on several projects have lamented the vaccines relatively low reduction in severe malaria when used alone and say it costs too much, despite the clear cost-benefits and efficacy synergies the WHO demonstrated when piloting the vaccine in real-world contexts.

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Other concerns include the logistical challenges in distributing the vaccine and the potential availability of more effective treatments in the future.

To be sure, promising treatments using monoclonal antibodies and an mRNA vaccine are under investigation. And early results on another experimental vaccine report higher efficacy than seen in earlier vaccines. But experimental vaccines have not been studied in the thousands of people required to establish a vaccine is safe and effective over the longer term.

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The malaria vaccine now in hand could save millions of lives in just a few years, and there is no time to wait.

Progress in the fight against malaria has stalled in recent years, and was then knocked off track by the pandemic. The world saw a 40% decline in malaria mortality from 2000 to 2015, and then mortality held steady for several years. But in 2020, deaths rose 12%, largely due to Covid-19-related disruptions.

Gavi, an alliance of countries and private funders working to boost global immunization, has pledged a $155.7 million investment via grants and other support to introduce the vaccine in Ghana, Malawi, and Kenya.

As public health practitioners in malaria prevention and control now working to save mothers and children from this devastating disease in several countries we cant fathom hesitating in embracing this groundbreaking tool now.

One objection to the vaccine, known as RTS,S, is its relative cost. The WHO estimates the average price to be $5 per dose, while existing interventions like insecticide-treated bed nets average about $1 each.

Yet the WHO found the vaccine to be overall highly cost effective, comparable to other new vaccines and malaria treatments, with no negative effect on the uptake of other preventive measures, such as insecticide-treated bed nets. A related hesitation is that the vaccines efficacy against severe malaria when used alone hovers around 30% in large trials. But taming the parasite that causes malaria with thousands more genes than a virus requires a multi-pronged plan of attack.

For example, when coupled with seasonal malaria chemoprevention (an antimalaria medicine given intensively at times of high transmission), the vaccine has been found to be 60% effective. The combination substantially lowered the incidence of severe malaria and death from malaria than either intervention alone. Its further proof that a variety of approaches can have a bigger impact when used in tandem.

And making the vaccine available as an option in addition to bed nets and seasonal malaria chemoprevention resulted in more than 90% of children under five having access to at least one of these tools.

These percentages arent just numbers on a page. They can translate to tens of thousands of lives saved.

Whats more, the additional public health impact of the vaccine on top of existing interventions is estimated at 200 to 700 deaths averted per 100,000 children vaccinated. The cost per life saved is comparable to other new vaccines.

What would that look like in real life?

Nigeria, Africas most populous nation, is home to an estimated 31 million children under age five. In 2020, more than 130,000 children in this age group perished due to malaria.

Using the lower-end value of 200 lives saved per 100,000 children vaccinated, that could translate into about 62,000 lives saved in just one year in Nigeria alone. These are children who will be alive, loved by their families, and hopefully able to enjoy bright and productive futures.

Another caution with the vaccine is the logistical complexity in distribution.

It is true that the vaccine requires four doses, more than many other childhood vaccines. That said, current seasonal malaria chemoprevention campaigns require three daily visits for four months, a similarly logistically challenging task that many countries in line for the malaria vaccine have mastered.

National scale-up of once-novel malaria interventions has historically led to a better understanding of their effectiveness and has yielded important lessons in operationalization. When insecticide-treated bed nets were being promoted for scale-up throughout Africa, for example, some doubted they could be made available for every person and feared potentially budget-busting costs. But once the effort began, approaches to reach isolated communities in cost-efficient ways were identified and coverage rates rose significantly, reaching previously unprotected people, including children under five. These campaigns have saved millions of lives.

Malarias ability to trick the human immune response and its sophisticated life cycle make it a wily adversary, turning the effort to combat it into a decades-long quest.

Vaccines have done amazing things for many of the worlds toughest health challenges, sometimes even creating the opportunity to eradicate a disease. But waiting for the perfect, 100% effective, one-dose, lifetime vaccine means waiting for years and millions more kids will die. Its time to use the full arsenal of tools to protect them.

Marian W. Wentworth is the president and CEO of Management Sciences for Health, a nonprofit that works to strengthen health systems around the world. Thomas Hall is the organizations senior principal technical advisor for malaria.

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The first malaria vaccine is here. Let's meet the moment - STAT