Good morning, and happy Monday! Special shout-out to my colleague Fenit Nirappil for his help with todays newsletter top. Send tips to McKenzie.Beard@washpost.com.
Todays edition: A growing trend of at-home medical testing is booming, but medical providers worry about the tests accuracy and reliability. Federal health officials released data showing gains in health-care coverage among minority communities. But first
How the CDC is taking on mpox this summer
With summer travel picking up and Pride festivities underway, public health experts are bracing for a return of mpox, the infectious disease formerly known as monkeypox.
The virus fueled a peak of up to 3,000 weekly cases in the United States between mid-July and late August 2022, predominantly spreading among men who have sex with men and killing at least 58 people. Vaccination efforts and behavioral changes quelled the outbreak, but the virus has continued to circulate at low levels throughout the country ever since.
On the ground, providers like Joseph Cherabie, medical director of the St. Louis STI/ HIV Prevention Training Center, says the mpox cases he has treated recently are largely in younger Black people and patients with uncontrolled HIV who are unvaccinated. He told my colleague Fenit Nirappil in a recent interview that more cases may be going undetected as mpox falls off the radar of patients and health providers, and noted that shots have become a harder sell as people have developed vaccine fatigue.
This comes as the Centers for Disease Control and Prevention is paying close attention to a version of the virus in the Democratic Republic of Congo linked to more fatalities.
I recently caught up with Christina L. Hutson, chief of the CDCs Poxvirus and Rabies Branch, about how the agency is working to raise awareness about mpox in hope of averting a summer surge. This conversation has been edited for clarity and brevity.
Health Brief: How are you approaching your outreach efforts this year?
Hutson: Our goal right now is creating awareness about the continued circulation of the virus in the U.S. and encouraging those who are unvaccinated or received only one dose to complete the two-dose vaccination series.
For the second year, were again working closely with the HHS Office of the Assistant Secretary of Health on a summer Pride initiative. This effort is really focusing on improving vaccine equity by partnering with health departments and community-based organizations to provide comprehensive sexual health services, including mpox vaccines, at local pride and LGBTQIA+ events.
Were also leaning on some of our existing partnerships with LGBTQIA+ organizations, and we have social media influencers we work with to make sure were getting that communication out there.
Finally, weve been funding the creation of materials that help address questions that men who have sex with men have raised about mpox and its vaccine. We now have social media tool kits, an mpox vaccine locator, and digital and print materials that have all been developed to help both clinicians and those at risk.
Health Brief: A recent report from the CDC indicates that there is long-term protection from the mpox vaccine, but Ive heard questions swirling about whether those at risk need a third dose. Can you explain why that isnt necessary?
Hutson: The paper looked at a total of 32,819 probable or confirmed mpox cases from the start of the outbreak up until May 2024, and we saw that less than 1 percent occurred in people who were fully vaccinated. This really illustrates that the vaccine is effective, and when we do see breakthrough infections, they are generally more mild.
The data set doesnt indicate that a booster is necessary, but it does illustrate that only 1 in 4 people who are eligible are fully vaccinated.
More patients are turning to a shadow system of DIY medical tests
A growing trend of at-home medical testing enabled by Silicon Valley start-ups and independent labs has boomed in recent years, The Posts Elizabeth Dwoskin, Daniel Gilbert and Tatum Hunter report. But medical providers worry this convenience comes with a slew of concerns, including the accuracy and reliability of these tests.
Venture capitalists and entrepreneurs told The Post they envision a world where frequent at-home testing is a routine part of life, enabling everyone to become the CEO of their own health, said Luca Springer, who co-founded a Silicon Valley start-up that aims to make cancer testing as simple as a home-pregnancy test.
But the boom angers some doctors, who argue that circumventing their offices can lead to questionable remedies, misdiagnosis or delayed medical care.
While the FDA generally reviews all but the lowest-risk medical tests, it doesnt supervise wellness tests marketed directly to consumers. Other start-ups avoid stringent FDA review by having physicians oversee some part of the testing process creating what experts call a two-track system of standards.
Its likely that some companies break the rules entirely, evading the agency and betting it wont police a fast-growing market, said Alberto Gutierrez, a former senior FDA official.
The FDA is starting to pay attention: Regulators finalized a contentious rule in April to begin holding lab-made tests to the same standards as conventional ones, phasing out a historically hands-off position in response to the ballooning industry. Still, businesses are charging ahead.
In other industry news, GlaxoSmithKline announced Friday that the FDA has approved its vaccine Arexvy for preventing respiratory syncytial virus (RSV) in adults ages 50 to 59 at increased risk.
The move to include those younger than 60 is aimed at addressing hospitalization rates among adults ages 50 to 64 with conditions such as COPD, asthma, heart failure and diabetes. The company said more than 13 million people have medical conditions that increase their risk of developing severe RSV outcomes.
Democrats ramp up patent battle with drug industry
Our colleague Dan Diamond sends us this dispatch.
Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) last week sent letters to eight pharmaceutical company CEOs, urging them to take down 130 patents listed in an FDA registry, I scooped on Friday.
Its the latest skirmish in a bigger fight over whether pharma companies are taking advantage of the FDAs Orange Book to box out generic competitors by making tiny tweaks to their products, like changing the design of an inhaler cap. If a patent is listed in the registry, it can effectively delay generic competition for another 2.5 years.
The Federal Trade Commission has twice warned pharmaceutical companies that hundreds of their patents are improperly listed in the Orange Book and must be taken down. The pharma industry has complied in some cases, but industry officials and some companies have pushed back, saying the Orange Book rules are unclear, and insisting theyre not trying to game patent rules.
The latest flash point: The FTC in April flagged more than 300 patents, including the 130 that Warren and Jayapal are focusing on.
Today is the deadline for pharma companies to either take down that batch of patents or reaffirm that they belong in the registry, a source familiar told me. Democrats say theyll continue to target more patents and push the industry, too.
Theyre making too damn much money off these inaccurate listings, Warren told me. And theyre not about to delist, unless they get a good hard shove from someone.
HHS sees improvements in health-care coverage for minorities
The Department of Health and Human Services released data Friday showing gains in health-care coverage among minority communities. The administration said the five reports highlight the progress made to increase affordable and quality health care.
From 2010 to 2020, there were significant declines in the percentages of uninsured people, with the highest decrease among Latinos. Black Americans saw their rate drop from 20.9 to 10.8 percent, Latinos from 32.7 to 18 percent, Asian American and Native Hawaiian/Pacific Islander from 16.6 to 6.2 percent and American Indians and Alaska Natives from 32.4 to 19.9 percent.
Today, external FDA advisers are set to convene to discuss the safety and efficacy of Eli Lillys experimental Alzheimers drug donanemab.
On Tuesday: A House appropriations subcommittee meets at 6 p.m. to discuss appropriations for fiscal 2025, including for the FDA.
On Wednesday: The Senate Finance Committee has scheduled a 10 a.m. hearing on youth residential treatment facilities.
From Wednesday to Friday, the Childrens Hospital Association will host its family advocacy days in D.C. Pediatric patients and their families will visit Capitol Hill to share their stories and advocate for policies that ensure childrens access to high-quality medical care.
Email fenit.nirappil@washpost.com and lena.sun@washpost.com with your questions or any suggestions for what youd like to see in future coverage of an outbreak of a highly virulent bird flu in dairy cattle that also infected at least three dairy workers.
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The devastated family of a fit and healthy young actor who died a fortnight after taking a Covid vaccine have called out the callous 'indifference' of society and government to her death.
Katie Lees, 34, took the first dose of the AstraZeneca vaccine in July 2021, driven by her desire to 'do her bit' to help bring lockdown to an end.
But just 13 days later her family were forced to make the harrowing decision to turn off her life support.
Ms Lees, an actor and comedian who lived in Sydney's inner-west, had suffered a severe vaccine-induced blood clot in her brain.
'The last time I ever spoke to her on the morning of July 22 (and) she said, "Im getting my AstraZeneca this afternoon." She said to me how proud she was for doing it,' Katie's father, Ian, told news.com.au.
'It turned out that was the last time I would ever speak to her. She was actually following the governments advice, trying to do the right thing for the sake of the community.'
Mr Lees, 66, said the hardest part about his daughter's death was that people didn't believe the vaccine had killed her and met the news with 'silence, mockery, discrediting and disbelief'.
'Wed say to people our daughter died from the AstraZeneca vaccine and theyd say, "Oh really? How do you know?",' he said.
In a public submission to the federal governments Covid Response Inquiry, Ms Lee's parents said they were galled by the 'indifference of our society to her death'.
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'Every morning, our first thought is how Katie died and the sinking feeling that we were used and discarded by our government, by AstraZeneca and by our society,' they wrote.
They added: 'Katie did not need the vaccine she wouldnt have died if she got Covid.
'Katie took this action, not because she was worried about getting Covid, but because she was deeply concerned about the impact of lockdowns on the life of communities and the mental health of individuals.'
The AstraZeneca vaccine was estimated to have saved millions of lives during the pandemic but it also caused rare, and sometimes fatal, blood clots.
In April, AstraZeneca admitted in a UK court that its vaccine could, in very rare instances, could lead to Thrombosis with Thrombocytopenia Syndrome, which causes people to have blood clots and a low blood platelet count.
The vaccine, which was discontinued in Australia in March 2023, was withdrawn globally last month with the manufacturer citing commercial reasons for the decision.
Of the 14 Australians acknowledged by the Therapeutic Goods Administration (TGA) to have died from Covid vaccines, 13 were from AstraZeneca and one from Moderna.
Just under 14 million AstraZeneca jabs were successfully administered across Australia, meaning that
Over 71 million jabs were successfully administered across Australia, meaning that vaccine deaths account for a miniscule fraction of the total.
Daily Mail Australia contacted AstraZeneca for comment.
Ms Lees developed headaches and a rash immediately after her vaccination but doctors did not think anything of it.
Just over a week later on AUgust 1 she woke up with a severe headache and started vomiting.
A CT scan showed a severe clot in her brain.
'Katie slipped into deep unconsciousness around 3pm and never regained consciousness,' her parents wrote in their submission to the inquiry.
'Despite this catastrophic brain injury, undergoing subsequent neurosurgery and being on life support, due to Covid restrictions, we were not permitted to visit Katie until two days after she was admitted.'
The devastated family said that they had been left 'emotionally, mentally and physically traumatised by the way Katie died, the lack of support from government and the pharmaceutical industry and the alienation we feel from the mainstream narrative in our society'.
They have called for an apology from the federal government and more clarity in public health communication about the safety of vaccines.
In addition, they want to see 'substantial increases in the amounts paid to the loved ones of someone who dies from a government-mandated vaccination program'.
The family who received $70,000 in compensation for Katies death, said they hated being branded 'anti-vaxxers'.
They set up the Katie Lees Foundation in March 2023 to support female artists an performers.
Buta funding body asked her parents to remove a statement saying that Katie died from the AstraZeneca vaccine because 'they were a "pro-vaccination" organisation', they claimed.
The Covid Response Inquiry is expected to publish its report in Spring.
Geneva, 7 June 2024 The Board of Gavi, the Vaccine Alliance today announced a series of decisions that provide a framework for an acceleration of global immunisation including approval of "Gavi 6.0", the Alliance's 2026-2030 strategy, expansion of Gavi's vaccine portfolio, and plans to support global health security and regional manufacturing through the African Vaccine Manufacturing Accelerator and a First Response Fund for use in future pandemics. The decisions were taken during a two-day meeting convened in Geneva from 6-7 June.
"Vaccines are one of the most impactful and cost-effective health and development interventions available today," said Professor Jos Manuel Barroso, Chair of the Gavi Board. "As we look to 2030 and progress against the Sustainable Development Goals amidst climate change and other challenges, the message is clear: the world must continue to invest in the transformative impact of vaccines and their ability to save lives and ensure our collective security."
To set the scene for two days of discussions on Gavi's future direction, the Board first reviewed progress for the current strategic period, noting that the Alliance is largely on track across mission indicators despite the disruptions caused by the COVID-19 pandemic. Progress includes critical advances in the push to reach 86 million girls with vaccines against human papillomavirus (HPV), with five new country launches since September 2023, and the new malaria vaccination programme, where 22 country applications have been approved and deeper collaboration with the broader set of malaria stakeholders, including the Global Fund, is underway. While there has been a 12% reduction in the number of outbreaks requiring a response between 2022 and 2023, it continues to be an area of concern that this remains far above pre-pandemic averages, primarily driven by surges in cholera and measles outbreaks.
PRIORITIES FOR GLOBAL IMMUNISATION THROUGH 2030
The Board approved the Vaccine Alliance's strategy for the period 2026-2030, known as "Gavi 6.0". The 6.0 strategy will be the most ambitious in Gavi's history: seeking to protect more people, against more diseases, faster than ever before. This means a continued focus on Gavi's core mission:
The new strategy will also make the Gavi model increasingly responsive to the evolving global context from climate change to the increasing threat of outbreaks, antimicrobial resistance, and fragility and conflict to continue meeting countries' and communities' needs. Key elements to this approach include proposed adjustments to Gavi's co-financing, eligibility and transition approach to ensure the continued sustainability of immunisation programmes; deeper partnerships with global and regional organisations, civil society and communities; differentiated, flexible and tailored support for fragile and humanitarian contexts; streamlining Gavi's operating model; and enhanced support for climate-sensitive and outbreak, epidemic and pandemic-prone diseases. The Alliance begin work on operational details, in preparation for implementation of the strategy beginning in 2026.
The projected impact of the next five years of work, as well as the total funding needs for the strategic period, will be announced on 20 June at the Protecting Our Future: Global Forum for Vaccine Sovereignty and Innovation, co-hosted by the African Union (AU), Africa Centres for Disease Control and Prevention (Africa CDC), Government of France and Gavi. The event will see the launch of both Gavi's Investment Opportunity for 2026-2030 as well as the African Vaccine Manufacturing Accelerator (AVMA), a first-of-its-kind US$ 1 billion financial instrument in support of sustainable vaccine manufacturing on the African Continent. Securing funding for the 2026-2030 period will be vital to ensuring the success of Gavi's strategy.
A critical part of each five-year period is the approval of a new Vaccine Investment Strategy (VIS), which looks at the pipeline of promising vaccines and vaccine candidates and evaluates how best to expand the portfolio of vaccines Gavi offers. The Board approved the 2024 VIS, which will include future vaccination programmes and learning agendas for tuberculosis (adolescent vaccines), group B streptococcus, and dengue fever (the latter investment conditional on availability of relevant data on the burden in Gavi-supported countries), as well as global stockpiles and learning agendas for vaccines against mpox and hepatitis E. In-principle approvals via the Vaccine Investment Strategy allow Gavi to begin market signaling and preparedness activities in advance, which is a critical part of Gavi's model to accelerate access to lower-income countries so new vaccines can be deployed as soon as they become available.
The Board also approved a learning agenda on vaccination against shigella, and, given the levels of coverage achieved, current epidemiology and country demand, recommended sunsetting of the routine COVID-19 vaccination programme at the end of 2025. Potential COVID-19 needs for a "worst-case scenario" after 2025 will be addressed through Gavi's emergency response mechanisms.
For mpox, the Board additionally approved that in the current strategic period, the Alliance would support the response to the on-going outbreak in the Democratic Republic of the Congo (DRC) and further potential outbreaks in surrounding countries including leveraging COVID-19 experiences to coordinate dose donations.
Following Board approval in 2023, decisions were made on the operational parameters for innovative vaccine sovereignty and health security mechanisms set up by Gavi in response to learnings from the COVID-19 pandemic.
The Board approved the final structure of the African Vaccine Manufacturing Accelerator, which will be launched on 20 June. In particular this includes the eligibility criteria designed to focus support on sustainable end-to-end vaccine manufacturing on the Continent. The Board also endorsed AVMA's governance mechanisms, which will involve the Gavi Board as well as partners including the AU, Africa CDC, UNICEF, WHO, manufacturers, and donors. The finalisation of AVMA sends an immediate signal to investors regarding Gavi's long-term commitment to support a sustainable African vaccine manufacturing base, and to improving African pandemic and outbreak vaccine supply resilience.
Another mechanism discussed was the Day Zero Financing Facility for Pandemics, a suite of instruments that will seek to make financing accessible in the first 100 days of a major public health emergency. The Board approved the parameters for the DZF's new First Response Fund, which sets aside US$500 million for rapid response to emergencies. Following the Board's decision, the scope of the First Response Fund was confirmed as core Gavi-eligible countries, with potential for exceptions if needed, and targeted mainly to WHO Public Health Emergencies of International Concern without existing vaccine programmes. The Board also agreed that the funds could be used to procure, alongside vaccines, syringes and ancillaries, personal protective equipment, cold chain, surge capacity, health system and community preparedness and response activities.
"The decisions taken today reflect our full Alliance of stakeholders aligning around a clear goal: ensuring Gavi's model continues to best support the countries and communities who are our partners," said Dr Sania Nishtar, CEO of Gavi. "In a complex and changing world, today's decisions will help Gavi deliver systematic impact faster than ever before."
German researchers have pointed out that the onset of excess mortality in early 2021 in the country coincided with the rollout of vaccines, which the team said warranted further investigation.
However, more recent data regarding side-effects has not been made available to the public, with countries keeping their own individual databases of harms, which rely on self-reporting by the public and doctors, the experts warned.
Researchers said that it was likely that the impact of containment measures, restricted healthcare and socioeconomic upheaval during the pandemic had contributed to deaths, although accepted that was difficult to prove.
Gordon Wishart, chief medical officer at Check4Cancer, and visiting professor of cancer surgery at Anglia Ruskin University, warned repeatedly that delaying cancer diagnosis would lead to deaths.
It was predicted early in the lockdown period that limited access to healthcare for non-Covid conditions would lead to delays in the diagnosis and treatment of time-critical conditions such as cancer, cardiac disease, diabetes and dementia and that this would lead to excess deaths from these conditions, he said.
NHS England data shows that per 100,000 people the cancer incidence was 521 in the pre-lockdown year, then fell to 456 in 2020-2021, suggesting around 45,000 cancers were missed in the first pandemic year.
The incidence rate rose to 540 per 100,000 the following year suggesting many cancers were diagnosed late, when treatment would be less effective.
Speaking about the potential for vaccine harm, Mr Wishart added: The authors are correct to point out that many vaccine-related serious adverse events may have been unreported, and point to the fact that the simultaneous onset of excess mortality and Covid vaccination in Germany is worthy of further investigation on its own.
The paper provides more questions than answers but, it is hard to disagree with their conclusion that further analysis is required to understand the underlying causes of excess mortality to better prepare for the future management of pandemic crises
By Kate Pickles Health Editor For The Daily Mail 17:24 10 Jun 2024, updated 17:50 10 Jun 2024
Patients could soon be given two-in-one flu and Covid jabs after trials found it was just as effective as single shots.
The combined vaccine from Moderna was found to provoke a higher immune response than separate single jabs, according to new data from the firm.
The NHS currently uses Moderna's Spikevax vaccine alongside Pfizer/BioNTech's Comirnaty for Covid-19 for its booster programmes.
But a newer version of Spikevax has been created and tested by Moderna, which includes a dose of flu vaccine.
Experts predict these combination jabs could see patients only needing one jab for protection against both illnesses as soon as 2025, with equivalents being developed by competitors Pfizer and BioNTech.
The findings from Moderna showed that the mRNA-1083 vaccine met its goals and led to higher immune responses against flu and Covid than other single vaccines currently in use, including the current Spikevax.
It is the first time final phase 3 data for a combined vaccine has been published by any firm.
The mRNA-1083 jab matched or bettered current flu jabs and was better than the existing Spikevax at making the body produce antibodies.
Scientists believe this is likely because it had been designed to fight more recent variants circulating around the world.
The randomised controlled trial involved two groups of about 4,000 people each, with the first group aged 65 and over testing the new jab compared with a flu vaccine, Fluzone, and the current Spikevax jab.
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The second group included adults aged 50 to 64 and included use of the flu jab Fluarix.
Stephane Bancel, chief executive of Moderna, told the BBC he hoped the vaccine could be made widely available in 2026 - or perhaps, 2025.
He said: Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses.
Moderna is the only company with a positive phase 3 flu and Covid combination vaccine.
Building on the momentum of positive phase 3 data across our respiratory portfolio, we continue to address significant unmet medical needs and advance public health.
A combined flu and Covid vaccine from Moderna provokes a higher immune response than separate single jabs, according to new data from the firm.
The results raise hopes the new vaccine could be approved by regulators this year, with the possibility of being rolled out on the NHS.
At the moment, Modernas Spikevax vaccine for Covid-19 is used in the NHS booster programmes, alongside Pfizer/BioNTechs Comirnaty.
A newer version of Spikevax has been created and tested by Moderna which includes a dose of flu vaccine.
The combination means people would only need one jab rather than two, as at the moment, to give them full protection against Covid-19 and flu.
This is the first time final phase 3 data for a combined vaccine has been published by any firm.
The findings from Moderna showed that the mRNA-1083 vaccine met its goals and led to higher immune responses against flu and Covid than two other single vaccines currently in use, including the current Spikevax.
Stephane Bancel, chief executive of Moderna, said: Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses.
Moderna is the only company with a positive phase 3 flu and Covid combination vaccine.
Building on the momentum of positive phase 3 data across our respiratory portfolio, we continue to address significant unmet medical needs and advance public health.
The randomised controlled trial involved two groups of about 4,000 people each, with the first group aged 65 and over testing the new jab compared with a flu vaccine, Fluzone, and the current Spikevax jab. The second group included adults aged 50 to 64.
The FDA expanded the approval of GSK's respiratory syncytial virus (RSV) vaccine (Arexvy) to include adults ages 50 to 59 at risk of RSV-related lower respiratory tract disease (LRTD) due to underlying conditions, the company announced on Friday.
Previously the adjuvanted RSV prefusion F protein-based vaccine had been approved only for adults 60 and older; it is currently recommended for use via shared decision-making by the CDC and Advisory Committee on Immunization Practices.
According to the vaccine maker, an estimated 13 million U.S. adults ages 50 to 59 years have medical conditions -- e.g., asthma, chronic obstructive pulmonary disease, diabetes, heart failure -- putting them at increased risk of RSV-related LRTD and its serious consequences, including pneumonia and death.
"When it comes to the risks associated with RSV, age is just a number, an important number, but not the only factor to consider," Ann Falsey, MD, of University of Rochester School of Medicine in New York, said in a statement from GSK. "Many adults in this age group have underlying health conditions that place them at increased risk for serious illness with RSV infection compared with those without these conditions. Now there is a vaccine approved that can help protect them."
About 42,000 hospitalizations occur each year in the U.S. among adults ages 50 to 64 years old, according to a systematic review and meta-analysis. That compares to approximately 159,000 annual hospitalizations in U.S. adults 65 and older.
The new approval was based on results of a double-blind phase III multinational trial that demonstrated noninferior immune responses with the vaccine for 1,140 participants ages 50 to 59 (half of whom had high-risk conditions for RSV-LRTD) versus older adults. In both of the younger groups, RSV-A and RSV-B neutralization titers were similar 1 month after administration of a single vaccine dose compared to the older group.
Safety and reactogenicity were consistent with the pivotal trial data for adults 60 and over, said GSK, with most adverse events (AEs) being mild to moderate and also transient. In the adults ages 50 to 59, the most commonly reported AEs were pain at the injection site (76%), fatigue (40%), myalgia (36%), headache (32%), arthralgia (23%), erythema (13%), and swelling (10%).
Safety information in the labeling also includes warnings about the potential for severe allergic reaction and syncope after administration, and that immunocompromised people may have a diminished immune response.
Ian Ingram is Managing Editor at MedPage Today and helps cover oncology for the site.
GSKs Arexvy has become the first respiratory syncytial virus (RSV) vaccine to be approved by the US Food and Drug Administration (FDA) for use in adults aged 50 to 59 who are at an increased risk of RSV-caused lower respiratory tract disease (LRTD).
The regulators decision comes just over a year after it approved Arexvy for use in adults aged 60 years and older.
RSV is a common contagious virus affecting the lungs and breathing passages. Although most people can recover within a week or two, 13 million adults aged 50 to 59 years in the US have a medical condition that increases their risk of severe RSV outcomes.
The virus can worsen conditions including chronic obstructive pulmonary disease, asthma and chronic heart failure, and can lead to severe outcomes such as pneumonia, hospitalisation and death.
GSKs Arexvy contains a protein from the surface of the RSV virus and teaches the immune system how to defend itself against disease.
The FDAs latest approval was supported by positive results from a late-stage trial evaluating the immune response and safety of Arexvy in adults aged 50 to 59 years, including those at an increased risk for RSV-LRTD due to underlying medical conditions.
Tony Wood, GSKs chief scientific officer, said the decision reflects the importance of broadening the benefits of RSV immunisation to this patient population.
For those with underlying medical conditions, RSV can have serious consequences, so we are proud to be the first to help protect them from RSV-LRTD, he said.
Beyond the US, Arexvy is approved to prevent RSV-LRTD in adults aged 60 years and older in over 40 countries. GSK has also filed regulatory submissions to extend the use of the vaccine to higher-risk adults aged 50 to 59 in Europe and other markets.
Professor Ann Falsey, University of Rochester School of Medicine, said: When it comes to the risks associated with RSV, age is just a number, an important number, but not the only factor to consider.
Many adults in this age group have underlying health conditions that place them at increased risk for serious illness with RSV infection compared with those without these conditions.
A recent study has sparked another round of headlines claiming that COVID vaccines caused excess deaths. This was accompanied by a predictable outpouring of I-told-you-sos on social media.
Excess deaths are a measure of how many more deaths are being recorded in a country over what would have been expected based on historical trends. In the UK, and in many other countries, death rates have been higher during the years 2020 to 2023 than would have been expected based on historic trends from before the pandemic. But that has been known for some time. A couple of years ago I wrote an article for The Conversation pointing this out and suggesting some reasons. But has anything changed?
The authors of the new study, published in BMJ Public Health, used publicly available data from Our World in Data to determine which countries had statistically significant excess deaths in other words, excess deaths that couldnt be explained by mere random variation.
They studied the years 2020 to 2022 and found that many, but not all, countries did indeed report excess deaths. The authors did not try to explain why these excess deaths occurred, but the suggestion that COVID vaccines could have played a role is clear from their text and indeed widely interpreted as such by certain newspapers.
There is no doubt that a few deaths were associated with the COVID vaccines, but could the vaccination programme explain the large number of excess deaths 3 million in 47 countries that have been reported?
Based on death certificates, during 2020 and 2021 there were more deaths from COVID than estimated excess deaths in the UK. So during the year 2021 when most vaccine doses were administered, there were actually fewer non-COVID deaths than would have been expected. It was only in 2022 that excess deaths exceeded COVID deaths.
If the vaccination campaign was contributing to the excess deaths that we have seen in recent years, then we should expect to see more deaths in people who have been vaccinated than in those who have not. The most reliable analysis in this regard was done by the UKs Office for National Statistics (ONS). In this analysis, the ONS matched death registrations with the vaccine histories of each death recorded. They then calculated age-standardised death rates to account for age differences between those vaccinated and those not.
What the ONS found was that in all months from April 2021 to May 2023, the death rate from all causes was higher in the unvaccinated than in people who had been vaccinated at least once.
That deaths from all causes were lower in the vaccinated than the unvaccinated should come as no surprise given that COVID was a major cause of death in 2021 and 2022. And there is ample evidence of the protective effect of vaccines against severe COVID and death. But what is even more convincing is that, even when known COVID deaths were excluded in the ONS report, the death rate in the unvaccinated was still higher, albeit not by very much in more recent months.
Some COVID deaths would certainly not have been recognised as such. But, on the other hand, people with chronic conditions, such as diabetes, were a high priority for vaccination. And these people would have been at increased risk of death even before the pandemic.
If the vaccine is not the cause of the excess deaths, what was?
The major cause of the excess deaths reported in the first two years of the BMJ Public Health study was deaths from COVID. But by 2022, excess deaths exceeded COVID deaths in many countries.
Possible explanations for these excess deaths include longer-term effects of earlier COVID infections, the return of infections such as influenza that had been suppressed during the COVID control measures, adverse effects of lockdowns on physical and mental health, and delays in the diagnosis of life-threatening infections as health services struggled to cope with the pandemic and its aftermath.
We do need to look very carefully at how the pandemic was managed. There is still considerable debate about the effectiveness of different behavioural control measures, such as self-isolation and lockdowns. Even when such interventions were effective at reducing transmission of COVID, what were the harms and were the gains worth the harms? Nevertheless, we can be confident that the excess deaths seen in recent years were not a consequence of the vaccination campaign.
Vaccine advisers to the Food and Drug Administration (FDA) today recommended switching the SARS-CoV-2 strain from the XBB.1.5 variant to JN.1 for fall vaccine formulations.
The recommendation marks the third remake for the COVID vaccine since 2022. The measure unanimously passed, 16 to 0. FDA officials, concerned about further evolution of JN.1, also asked the group to discuss the possibility of recommending an offshoot of JN.1, such as KP.2, that may more closely match currently circulating strains.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) was originally slated to meet on May 16 but postponed its discussion until today to allow time to gather more surveillance data and other information so that the group has the most up-to-date information.
JN.1 became the dominant strain in the United States at the end of 2023, but it continues to evolve. Offshoots such as KP.2 and KP.3now overshadowing the parent virushave an immune-evasive spike mutation combination that added more complexity to strain-selection considerations. Scientists have nicknamed the spike mutations FLiRT (FforLat position 456 andRforTat position 346).
The JN.1 FLiRT variants are partly responsible for case rises in some countries, with early US indicators showing aslight uptick from very low illness levels.
In late April, the World Health Organization vaccine advisory group recommended a switch to a monovalent (single-strain) vaccine that contains the JN.1 antigen.
At today's meeting, VRBPAC members heard from experts at the FDA, the Centers for Disease Control and Prevention (CDC), and vaccine manufacturers.
Ahead of the vote, Jerry Weir, PhD, who directs the viral products division in the FDA's vaccines research office, said nonclinical data from three vaccine manufacturers suggest that updated JN.1 lineage formulations prompt stronger neutralizing antibody responses against JN.1-descendant lineage viruses than the current monovalent XBB.1.5 vaccine. He also said serology data from people infected with JN.1 show improved antibody responses against JN.1 lineages, compared with sera from XBB-infected people, though neutralizing antibody responses appear to be reduced by recent mutations in many JN.1 lineage viruses.
After the vote, FDA officials asked advisory group members to weigh in on whether to select a specific JN.1 lineage, such as KP.2
During earlier presentations, a representative from Novavax said the company is already working on a JN.1 vaccine and that a switch to a newer lineage may mean the company won't be able to produce vaccine in time for the US market. Protein-based vaccines have longer manufacturing timelinesabout 6 months, which is similar to flu vaccinesthan mRNA vaccines do.
Most VRBPAC members said they thought JN.1 vaccines would provide good protection, and they didn't want to shut out the Novavax option for people who are unable to receive an mRNA vaccine or would prefer getting a protein-based vaccines.
Several members also said they weren't keen on "chasing variants." Melinda Wharton, MD, MPH, associate director for vaccine policy at the CDC's National Center for Immunization and Respiratory Diseases, said variants emerging when the updated COVID vaccines are released in August and September may not be the same as the ones the committee is discussing today, but will probably be related to JN.1.
Peter Marks, MD, who directs the FDA's Center for Biologics Evaluation and Research, pressed the group on whether it fully considered recommending a strain such as KP.2 that more closely matches circulating viruses. He also raised the possibility of exploring ways to give vaccine manufacturers a little more leeway on strains to include.
Michael Nelson, MD, PhD, professor of medicine and chief of the asthma, allergy, and immunology division at the University of Virginia School of Medicine, said he'd prefer a polyvalent vaccine containing JN.1 and KP.2, but for simplicity and based on reassuring neutralization data, JN.1 seems like a natural and obvious choice.
The group didn't vote whether to recommend a more specific strain, but FDA officials will take their views, alongside the earlier vote, into consideration when making its final recommendation to vaccine.
