WASHINGTON The Select Subcommittee on the Coronavirus Pandemic held a hearing titled Reforming the WHO: Ensuring Global Health Security and Accountability to examine the effectiveness of the World Health Organization (WHO), assess its response to the COVID-19 pandemic, and explore areas for improvement. Three Biden Administration officials from the U.S. State Department, U.S. Agency for International Development, and U.S. Department of Health and Human Services were in agreeance that the Chinese Communist Party was not transparent in sharing COVID-19 information with the world and that the WHO must be reformed before the world faces another pandemic. Select Subcommittee members discussed the existing, severe flaws within the WHO framework, described the CCPs cover-up of COVID-19 which was aided by the WHO and demanded American interests be placed at the forefront of WHO reform discussions. Throughout the pandemic, the WHO shied away from placing any blame on China and must be held accountable. The Select Subcommittee remains committed to revealing any wrongdoing by China, the WHO, and other public health officials in order to prepare our country for the next health crisis.
Key Takeaways
The World Health Organization caved to political pressure from the Chinese Communist Party and placed CCP interests ahead of global public health. It is now time to hold China accountable for its intentional coverup of COVID-19.
Select Subcommittee on the Coronavirus Pandemic Chairman Brad Wenstrup opened todays hearing by detailing four major examples of the WHO bowing to political pressure from the CCP: We saw the WHO deny that COVID-19 was spread via human-to-human transmission, based entirely on the word of the Chinese government. The WHO delayed naming COVID-19 a Public Health Emergency of International Concern, a World Health Organization procedure that, amongst other things, would have allowed for the procurement and distribution of scarce supplies, all because the Chinese Communist Party told them the spread was under control. The WHO delayed serious measures to counter the global spread of COVID-19, because the CCP was only worried about their own bottom line. When the WHO produced a report evaluating the possible origins of COVID-19, it became unquestionably evident that the entire report was nothing but more Chinese propaganda.
Biden Administration officials from the U.S. State Department (State), U.S. Agency for International Development (USAID), and U.S. Department of Health and Human Services (HHS) all agree that the World Health Organization is in urgent need of reform.
Ms. Loyce Pace, Assistant Secretary for Global Affairs at HHS, admitted that the WHO is not sufficiently structured to serve the world and described the way HHS is working to reform the organization: If the WHO didnt exist, we would have to create it. That said, the COVID-19 pandemic also revealed major gaps in our global health security architecture, including and importantly, at WHO. Working with likeminded Member States, the U.S. is leveraging our seat at the table to drive dialogs and solutions required today, because unfortunately, weve learned the hard way that this is in our national interest.
Ambassador John Nkengasong, Senior Bureau Official for Global Health Security and Diplomacy at State, committed the Biden Administration to ensuring the WHO implements comprehensive reform: This administration is firmly committed to ensuring the WHO implements a comprehensive set of organizational reforms, particularly to strengthen its governance, budgetary and financial management processes and improve oversight to strengthen the organizations efficiency and effectiveness.
Dr. Atul Gawande, Assistant Administrator for Global Health at USAID, recognized the failures of the WHO during the COVID-19 pandemic and noted USAIDs role in reforming the WHO in preparation for a future health emergency: The COVID-19 pandemic exposed significant fractures in our global health security systems and structures, including at WHO. In lockstep with our interagency partners, USAID continues to push for critical reforms at WHO, applying lessons learned from recent disease outbreaks to increase effectiveness, transparency, agility, and accountability to better respond to future health emergencies and meet our other public health goals.
As the WHO drafts a new Pandemic Accord and amendments to the International Health Regulations, it is essential that American interests and sovereignty are protected.
Dr. Atul Gawande explained the importance of protecting American sovereignty when Member States meet to discuss WHO reforms: We want respect for our sovereignty, and so we also limit how much WHO can control or demand things of us. And that is one of the challenges here, that we are protective of our own sovereignty and therefore do not want to have those tools challenged or potentially challenge us or other Member StatesWere looking for a three-level set of tiers so that there is an earlier indication when countries have a health issue developing of concern, there are clearer standards about what transparency requires, and then clear requirements that WHO has to live up to for reporting, making public and indicating when countries are not adhering to those.
Member Highlights
Select Subcommittee on the Coronavirus Pandemic Chairman Brad Wenstrup (R-Ohio), D.P.M, elicited agreement between all three executive branch witnesses that China was not sufficiently transparent or forthcoming throughout the COVID-19 pandemic.
Chairman Wenstrup: With your knowledge of what we have now and looking at COVID-19, I ask, was China, in your opinion, forthcoming and transparent regarding COVID-19?
Assistant Secretary Pace: With regards to your question, its an important one, especially because we have a lot of lessons to learn regarding COVID-19. Unfortunately, one of those lessons is the importance of transparency. We are quite disappointed and share your frustration with the government of China for not being as forthcoming as they should have been.
Ambassador Nkengasong: We fully agree with your opening remarks about the trust capital that is required to deal with global diseases. That comes with the ability to be fully transparent, to be accountable, to report in a timely fashion, and also to cooperate. All of these elements were lacking in Chinas ability to cooperate with WHO and the world.
Assistant Administrator Gawande: Im in complete agreement with my colleagues. China was not forthcoming early on about human-to-human transmission.
Committee on Oversight and Accountability Chairman James Comer (R-Ky.) shed light on HHS Global Affairs Assistant Secretarys effort to evade questions about Chinas culpability during COVID-19.
Oversight Chairman Comer: Do you believe that the Chinese government ought to be held accountable for the lack of cooperation in the early days of the pandemic? Ms. Pace.
Assistant Secretary Pace: Thank you, sir. We do think that the International Health Regulations, in improving those, will make all countries
Oversight Chairman Comer: But should China be held accountable?
Assistant Secretary Pace: We believe all countries should be held accountable.
Oversight Chairman Comer: Do you not think Chinas a little special in this situation since it came from China, and they completely lied and were not truthful with the world population about the outbreak of COVID 19. That they had veto power over who America put on boards and rejected, reports that we now know could have been helpful.
Assistant Secretary Pace: I share your frustration with Chinas lack of cooperation.
Oversight Chairman Comer: But shouldnt we hold China accountable?
Assistant Secretary Pace: Well, thats something that were trying to do by amending the International Health Regulations and ensuring that violations cant happen in the way that they did previously.
Rep. Nicole Malliotakis (R-N.Y.) laid out indisputable evidence that covering up the failures of the Chinese Communist Party was common practice at the World Health Organization throughout the pandemic.
Rep. Malliotakis: Im really concerned about what weve seen from the WHO throughout the COVID-19 pandemic. I mean, they deny human-to-human spread of COVID-19 based solely on CCP propaganda. It was not until January 23, 2020 that the WHO finally recognized that human-to-human spread was occurring. It was a month after the first warnings. The WHO delayed naming COVID-19 a public health emergency. It delayed serious measures like travel restrictions because the CCP told them the spread was under control. The WHO continued to praise the Communist Chinese Partys failed efforts to combat the pandemic despite a globally recognized cover up.
And then when we pushed for an investigation into the origins, the CCP was given full veto power over inclusion of American scientists. The Communist Chinese vetoed the three Americans put forward by our government to be in that investigative body, and the CCP was given full power to edit and alter the final reports.
Rep. Rich McCormick (R-Ga.), M.D., argued that American interests should always be at the forefront of global discussions on reforming the World Health Organization in order to ensure U.S. sovereignty is prioritized.
Rep. McCormick: Let me be clear, the United States should never ever allow international organizations, specifically the World Health Organization, to impede our sovereignty, which I know you just reaffirmed. With that said, I think that when you designed the World Health Organization, it was intended to be idea gathering, an observer, an informant to nations around the world with a goal of providing interchange of information from different health care organizations for emergencies.
However, the Biden administration must ensure the WHO authority is limited to setting public health standards and providing a forum for countries to exchange information, but not to be given greater authority to infringe on our nations sovereigntyCan you both commit to complete transparency during these processes?
Assistant Secretary Pace: Yes, sir.
Ambassador Nkengasong: Yes.
Rep. Michael Cloud (R-Texas) slammed the World Health Organization for caving to the political interests of the Chinese Communist Party instead of prioritizing global public health.
Rep. Marjorie Taylor Greene (R-Ga.) broke down major American concerns with the Biden Administrations proposed amendments to the International Health Regulations a legally binding agreement that requires all countries to conduct surveillance of potential international health threats.
Rep. Greene: The International Health Regulations, the IHR, is a treaty of the WHO, meant to usher in a new era of global public health that requires all member states to cooperate to make the world more secureIn an October 2023 meeting, the working group compiling the amendments for the 77th World Health Assembly in May 2024 was told that they do not have to produce their document before the meeting.
Some of the amendments include expanding the ability of the WHO Director-General to declare public health emergencies, to include regional declarations as well as intermediate threats, allowing Director-General to act on information in the public domain without verification from Member States, and creation of a compliance committee to enforce their rules. I can assure you the American people do not want the WHO enforcing any rules on their own personal decisions regarding their health.
If certain amendments are adopted next year, sovereign countries, including the United States, would be obligated to adhere to the treaty. The Biden administration led the charge for amendments to the IHR, including a new compliance committeeThe move toward a global health security state is reliant upon surveillance, which relies on data. Remember China? Thats what they did to their citizens and still do. The treaty and the IHR call for more sharing of personal health data in the name of safety and outbreak prevention. Thats an invasion of privacy for the American people.
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The purpose of this notification is to inform you that based on the Los Angeles County definition of close contact, you may have been exposed to COVID-19 if you were in attendance at the City of Burbank, cake cutting ceremony at the City Hall Rotunda, and the Council Meeting in City Hall Council Chambers on Tuesday, December 12, 2023. Close contact means sharing the same indoor airspace with someone with COVID-19 for a total of 15 minutes or more in a 24-hour period during the contagious period.
Published on: December 14, 2023
10:24 AM
The Ministry of Health announced yesterday the discovery of a man infected with Monkey Pox in Phnom Penh.
The 28-year-old man from Pesey village, Toek Thla commune in Sen Sok district developed symptoms similar to genital warts on November 30 which later spread to the right side of his neck, cheeks, forearms and legs, so he was sent for testing at the National Institute of Public Health on Monday.
The man tested positive for the Monkey Pox virus and was placed in hospital isolation, however, the ministry in a statement did not specify where the man contracted the disease.
The ministry said: The Ministry of Healths emergency response team is now working with authorities to locate the source of the infection, as well as identify other suspected cases to prevent transmission in the community, as well as conduct health education campaigns in the village where the man resides.
Ly Sovann, Director of the Communicable Disease Control Department, could not be reached for comment yesterday.
The ministry has advised health workers to implement preventive and control measures in hospitals and health centres to stop further infections, especially to remain vigilant and identify patients suspected of having Monkey Pox symptoms and isolate them.
The virus is transmitted from person to person through sexual contact and direct contact with wounds, body fluids, and contact with or use of a patients belongings.
The ministry added that the virus is also transmitted from mother to child through the umbilical cord during or after birth and through direct contact with infected parents.
As a precautionary measure, the ministry recommends having sex with a condom and avoid multiple partners. Avoid contact with people showing Monkey Pox symptoms, do not share materials with patients and wear a mask if in the vicinity of a person with symptoms. In addition, regularly wash your hands with soap or alcohol.
The ministry also advised individuals suspected or confirmed of having Monkey Pox to be isolated. People showing symptoms should consult a doctor for testing of the virus or call 115 for advice and consultation.
Dr Quach Mengly, a public health expert, expressed concern over the discovery of Monkey Pox in Phnom Penh, noting that the disease is rare in Cambodia.
He said that although there are no reported deaths from Monkey Pox in Cambodia, everyone should still be very careful, especially in preventing the spread of the virus in the community as the virus is transmitted through sexual intercourse, body fluids and direct contact with patients.
He said that in addition to preventing the spread of the virus through hygiene measures, there is also a vaccine.
He said that if there was an outbreak of the disease in the community, the ministry would announce a vaccination campaign against the virus.
Few forces have killed off talented people before their time with quite the effectiveness of tuberculosis. Theres Chekhov, Chopin, Orwell, Kafka, Keats, Thoreau, Emily Bront all brought down by the bacterium before they reached the age of 50.
Their ranks are still growing. About 1.3 million people died of TB in 2022, and while deaths were falling pre-pandemic, the Covid-19 era saw progress stall. At this point, its annual death toll exceeds that of HIV/AIDS or malaria. The one vaccine against it was created in 1921 and does not protect adults or adolescents.
Yet the world has not mustered much in the way of resources against the disease. The New York Timess Stephanie Nolen notes that $5.8 billion a year in treatment funds and $1 billion a year in research funds goes to fighting TB in low- and middle-income countries. By contrast, the equivalent figure for HIV/AIDS treatment is about $20 billion annually. Thats a worthy cause, of course, but considering its enormous death toll, TB has drawn the short straw.
To some degree, the relative neglect of TB (including by me I write much more about malaria) has to do with the scale of the challenge it poses.
TB is a hard disease to vaccinate against. While most vaccines target viruses, TB is a bacterium, and one with a strange lifecycle. In the vast majority of people it infects, it is latent, not causing symptoms or becoming contagious. The population of people carrying around latent TB infections is truly massive. A recent study compiling blood test estimates found that about 24 percent of people on Earth have TB, with rates ranging from 1214 percent in Europe and the Americas to over a third in Africa and Southeast Asia.
A small share of people with these latent infections (from 5 to 15 percent) develop symptomatic, contagious cases. Often these are treatable with antibiotics but a significant share of cases are drug-resistant, access to antibiotics is uneven in low-income countries, and mortality is particularly high in people with both HIV and TB.
These dynamics complicate the task for a vaccine. Ideally you would want it to both reduce the share of people with latent infections and reduce the odds that those infections become active. But we dont have whats called a correlate of protection for TB: a set of indicators of a persons immune system that show they can resist initial infection, or can keep an infection from becoming active.
That makes testing treatments and vaccines tricky and expensive. Testing needs to be truly massive in scale, given the relatively small share of people who gain new latent infections, or see infections go active, in a given year. M72, the most promising vaccine candidate as of right now, is currently undergoing a phase III trial with a staggering 26,000 participants. It cost donors $550 million to fund it more than half the annual research budget for TB. And theres still a chance it wont work, or even that the trial wont pick up enough cases to show anything either way.
If every promising TB vaccine costs more than half a billion dollars to test, we are not going to test very many. Even if M72 works, and I very much hope it does, it may still have limitations, as the existing vaccine for children does; and there may be other models that are cheaper to manufacture, or that prove more effective. We want to be testing those, too, and we wont if testing them is prohibitively expensive.
In 2016, the FDA approved a cholera vaccine whose phase III test only included 197 people. Thats a tiny fraction of the 26,000 in the TB vaccine trial. This earlier trial was much, much cheaper but still resulted in a working, approved vaccine.
What was the trick? The cholera vaccine was assessed using a challenge trial. 134 of the volunteers in the study actually ingested the cholera bacterium after receiving their vaccine or placebo. Those who got infected were, of course, given antibiotics, fluids, and other necessary treatments. No one got hurt. But their sacrifice enabled researchers to find an effective cholera vaccine for a fraction of the price of a field trial with thousands of people.
Human challenge trials are a tested and reliable method, having been used for decades with great success to develop malaria treatments and prophylactics. But they have yet to be used on tuberculosis. Developing a challenge approach takes time, and while that investment has been made for malaria and cholera, it hasnt been for TB yet. Thats a shame, because they could provide a way around the huge numbers of people TB trials typically need to detect results. Instead of waiting months for a handful out of a group of thousands of participants to be exposed to TB, researchers could expose several dozen volunteers at once, see how much protection vaccines offer, and proceed from there.
This may sound dangerous at first glance, but the risks are small. As with other challenge trials, the researchers would use a weakened or attenuated version of the pathogen and would provide immediate and comprehensive treatment. One paper examining the idea estimated that a challenge trial would pose a risk of death of about 1 in 1,600, at the high end. For context, thats less than half the death risk associated with working as a trucker for five years, and about one-sixth the danger of working as a logger for five years. We let people do those things for money because we value lumber and quick shipping. Theres something to be said for letting people take more modest risks to save lives.
Luckily, several researchers are trying to develop models for tuberculosis challenges. One would use the 1921 vaccine itself as a substitute for the bacterium, because the vaccine is already in essence an attenuated form of TB. Given that the vaccine is already broadly accepted, it seems hard to argue with the acceptability of this approach. Another option involves an artificial strain of tuberculosis that has been modified to rely on certain compounds that can be withdrawn at any time, effectively offering a kill switch for the bacteria and allowing study researchers to fully cure participants at the end of the trial. Both of these could provide a pathway to challenge trials with extremely minimal risks for participants.
Helen McShane, Eric Rubin, Sarah Fortune, and the dozens of other researchers developing these models are, I think, doing some of the highest-impact work in global health right now. But they need help: regular funding, collaborative drug agencies, and a general public thats supportive of letting volunteers contribute to the fight against tuberculosis this way.
A version of this newsletter originally appeared in the Future Perfect newsletter. Sign up here!
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Control and Prevention Director Mandy Cohen testifies before the House Oversight and Investigations Subcommittee November 30, 2023. The committee heard testimony on the topic of "Unmasking Challenges CDC Faces in Rebuilding Public Trust Amid Respiratory Illness Season." (Photo by Win McNamee/Getty Images) Getty Images
As U.S. Covid-19 hospitalizations and deaths increase this month as a result of yet another wave of infections sweeping the nation, the Centers for Disease Control and Prevention is telling people to get vaccinated. However, as its main message, instead of touting the vaccines effectiveness at greatly reducing the risk of severe disease and death the CDC asserts the vaccines ability to prevent the spread of Covid-19, which is largely inaccurate. Such problematic messaging may exacerbate the publics decline in trust in the CDC.
Nationwide Covid-19 deaths are rising again. The weekly total is over 2,000 for the first time since the beginning of the year. In the past week, the average weekly death toll increased by 25%, while hospitalizations are up by nearly 18%.
After a tally of more than 1.2 million Covid-19 deaths since the beginning of the pandemic, the last thing the U.S. wants to see is a winter spike.
As countermeasures, people whove tested positive, have symptoms or been exposed to someone with Covid-19 should consider the use of KN95 or N95 masks, proper ventilation in public indoor settings and avoidance of close contact with others. Furthermore, its advised to get vaccinated or receive updated boosters, especially those in at-risk categories such as the elderly and immune-compromised.
But CDCs messaging on vaccination leaves something to be desired. This week, the agency posted: The only thing we want you to spread this holiday season is love and cheer. Prevent the spread of #flu, #COVID, and #RSV by getting vaccinated.
While vaccination is certainly recommended as a way to diminish the chance of serious illness, its not going to do much to curb the spread of Covid-19. Its erroneous to suggest that vaccines are an effective tool to prevent transmission of the coronavirus.
Messaging matters, especially when it emanates from a public health agency thats been under fire for several years for inconsistent and at times wrong messages.
Theres plenty of evidence to support the use of vaccines to reduce disease severity and death. This is indeed what the CDC ought to emphasize when it addresses the public about the need for vaccination and boosters.
Since Covid-19 vaccines became widely available in the spring of 2021, there has been a sizable gap in the fatality rate between the unvaccinated and vaccinated.
A Commonwealth Fund study estimated that through November 2022, Covid-19 vaccines prevented more than 18.5 million U.S. hospitalizations and 3.2 million deaths.
By the end of 2022, data began to show that the majority of Covid-19 deaths were among the vaccinated. But this doesnt imply that vaccines and boosters are ineffective. The absolute number of deaths may now be higher in vaccinated individuals, but this is because there are far more vaccinated than unvaccinated individuals.
Its the relative rates of Covid-19 fatalities among the unvaccinated versus the vaccinated that are relevant. These rates demonstrate unequivocally the effectiveness of vaccines. Its clear, for example, from the chart below, which enumerates Covid-19 deaths per 100,000 people stratified by vaccination status, that being vaccinated protects against death.
The disparity in death rate between the unvaccinated and vaccinated did shrink in early 2023. The last posted data point in the graph is April 2023. For the nation as a whole we dont have more recent data. However, for a state like Washington we do. There continues to be a differential in death rates and severity of illness. From September 14 to October 11, 2023, unvaccinated individuals in the state of Washington were between 1.3 and 2.5 times more likely to die from Covid-19 compared to those who received at least one booster dose in addition to having completed the primary series of two vaccinations. And from October 6 to November 2, 2023, unvaccinated individuals were between two and 4.5 times more likely to be hospitalized with Covid-19 than those who received at least one booster dose on top of the first two shots.
Its this kind of evidence that should be highlighted in CDCs messaging on the importance of vaccines in the effort to prevent severe illness and death from Covid-19.
I'm an independent healthcare analyst with more than 24 years of experience analyzing healthcare and pharmaceuticals. Specifically, I analyze the value (costs and benefits) of biologics and pharmaceuticals, patient access to prescription drugs, the regulatory framework for drug development and reimbursement, and ethics with respect to the distribution of healthcare resources. I have approximately 110 publications in peer-reviewed journals, in addition to hundreds of articles in newspapers and periodicals. I have also presented my work at numerous trade, industry, and academic conferences. From 1999 to 2017 I was a research associate professor at the Tufts Center for the Study of Drug Development. Prior to my Tufts appointment, I was a post-doctoral fellow at the University of Pennsylvania, and I completed my PhD in economics at the University of Amsterdam. Before pursuing my PhD I was a management consultant at Accenture in The Hague, Netherlands. Currently, and for the past 6 years, I work on a freelance basis on a variety of research, teaching, and writing projects.
Key points:
The WHO Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) continues to meet regularly to assess the implications of SARS-CoV-2 evolution for COVID-19 vaccine antigen composition and advise WHO on whether changes are needed to the antigen composition of future COVID-19 vaccines. In May 2023, the TAG-CO-VAC recommended the use of a monovalent XBB.1 descendent lineage, such as XBB.1.5, as the vaccine antigen. Several manufacturers (using mRNA and protein-based and viral vector vaccine platforms) have updated COVID-19 vaccine antigen composition to monovalent XBB.1.5 formulations which have been approved for use by regulatory authorities.
The TAG-CO-VAC reconvened on 4-5 December 2023 to review the genetic and antigenic evolution of SARS-CoV-2, the performance of currently approved vaccines against circulating SARS-CoV-2 variants, and the implications for COVID-19 vaccine antigen composition. The twice-yearly evidence review by the TAG-CO-VAC is based on the need for continued monitoring of the evolution of SARS-CoV-2 and the kinetics of vaccine-derived immunity.
The published and unpublished evidence reviewed by the TAG-CO-VAC included: (1) SARS-CoV-2 evolution, including genetic and antigenic characteristics of earlier and current SARS-CoV-2 variants, and the impact of SARS-CoV-2 evolution on cross-neutralization and cross-protection following vaccination and/or infection; (2) Vaccine effectiveness (VE) of currently approved vaccines during periods of XBB descendent lineage circulation; (3) Antigenic cartography analyzing antigenic relationships of SARS-CoV-2 variants using nave animal sera and human sera following vaccination and/or infection; (4) Preliminary immunogenicity data on the performance of currently approved vaccines against circulating SARS-CoV-2 variants using animal and human sera; and (5) Cellular (T and B cell) immune responses following vaccination and/or infection. Further details on the publicly available data reviewed by the TAG-CO-VAC can be found in the accompanying data annex. Unpublished and/or confidential data reviewed by the TAG-CO-VAC are not shown.
The TAG-CO-VAC acknowledges several limitations of the available data:
Given the current SARS-CoV-2 evolution and the breadth in immune responses demonstrated by monovalent XBB.1.5 vaccines against circulating variants, the TAG-CO-VAC advises retaining the current COVID-19 vaccine antigen composition, i.e. a monovalent XBB.1.5 (e.g., hCoV-19/USA/RI-CDC-2-6647173/2022, GenBank: OQ054680.1, GISAID: EPI_ISL_16134259 or WHO Biohub: 2023-WHO-LS-01, GenBank: OQ983940, GISAID EPI_ISL_16760602) as the COVID-19 vaccine antigen.
Other formulations and/or platforms that achieve robust neutralizing antibody responses against currently circulating variants, including XBB- and BA.2.86 descendent lineages, can also be considered. In accordance with WHO SAGE policy, vaccination programmes can continue to use any of the WHO emergency-use listed or prequalified COVID-19 vaccines.
Given the limitations of the evidence upon which the recommendations above are derived and the anticipated continued evolution of the virus, the TAG-CO-VAC strongly encourages generation of the following data:
As previously stated, the TAG-CO-VAC continues to encourage the further development of vaccines that may improve protection against infection and reduce transmission of SARS-CoV-2.
An investigational mRNA vaccine used along with immunotherapy continues to show benefit for people with high-risk forms of the skin cancer melanoma, the drugmakers said Thursday.Related video above: New vaccine shows potential for lung cancer treatmentAt a three-year follow-up with trial participants who had had a stage III or IV melanoma fully removed but were at high risk of the cancer coming back, those who got the vaccine from Moderna along with Merck's Keytruda immunotherapy had a 49% lower risk of recurrence or death and a 62% lower risk of distant tumor cell spread or death compared with those who got Keytruda alone, the companies said in a news release.A two-year follow-up had found a 44% lower risk of recurrence or death and a 65% lower risk of distant metastasis or death in people who got Keytruda and the vaccine, called mRNA-4157/V940, compared with those who got Keytruda alone.About a quarter of the trial participants who got Keytruda plus the vaccine reported serious adverse events related to the treatment, compared with about 20% for those who got only Keytruda. The most common side effects attributed to the vaccine were fatigue, pain at the injection site and chills.The U.S. Food and Drug Administration first approved Keytruda, which boosts the immune system's ability to detect and fight cancer cells, for the treatment of certain cancers in 2014. The agency has granted a breakthrough therapy designation to mRNA-4157/V940 combined with Keytruda. This status expedites the development and review of drugs that are intended to treat a serious condition and that preliminary clinical evidence indicates may be a substantial improvement over available therapies.The data from the Phase 2b trial of the therapies has not been peer-reviewed or published in a professional journal. Moderna and Merck say they have begun Phase 3 trials on stage IIB-IV melanoma and non-small-cell lung cancer, and they plan to expand the research to include further types of tumors.According to the American Cancer Society, melanoma accounts for about 1% of all skin cancers, but it causes a majority of skin cancer deaths. The group estimated that in 2023, about 100,000 new melanomas would be diagnosed in the U.S., and almost 8,000 people would die from melanoma.CNN's Jamie Gumbrecht contributed to this report.
An investigational mRNA vaccine used along with immunotherapy continues to show benefit for people with high-risk forms of the skin cancer melanoma, the drugmakers said Thursday.
Related video above: New vaccine shows potential for lung cancer treatment
At a three-year follow-up with trial participants who had had a stage III or IV melanoma fully removed but were at high risk of the cancer coming back, those who got the vaccine from Moderna along with Merck's Keytruda immunotherapy had a 49% lower risk of recurrence or death and a 62% lower risk of distant tumor cell spread or death compared with those who got Keytruda alone, the companies said in a news release.
A two-year follow-up had found a 44% lower risk of recurrence or death and a 65% lower risk of distant metastasis or death in people who got Keytruda and the vaccine, called mRNA-4157/V940, compared with those who got Keytruda alone.
About a quarter of the trial participants who got Keytruda plus the vaccine reported serious adverse events related to the treatment, compared with about 20% for those who got only Keytruda. The most common side effects attributed to the vaccine were fatigue, pain at the injection site and chills.
The U.S. Food and Drug Administration first approved Keytruda, which boosts the immune system's ability to detect and fight cancer cells, for the treatment of certain cancers in 2014. The agency has granted a breakthrough therapy designation to mRNA-4157/V940 combined with Keytruda. This status expedites the development and review of drugs that are intended to treat a serious condition and that preliminary clinical evidence indicates may be a substantial improvement over available therapies.
The data from the Phase 2b trial of the therapies has not been peer-reviewed or published in a professional journal. Moderna and Merck say they have begun Phase 3 trials on stage IIB-IV melanoma and non-small-cell lung cancer, and they plan to expand the research to include further types of tumors.
According to the American Cancer Society, melanoma accounts for about 1% of all skin cancers, but it causes a majority of skin cancer deaths. The group estimated that in 2023, about 100,000 new melanomas would be diagnosed in the U.S., and almost 8,000 people would die from melanoma.
CNN's Jamie Gumbrecht contributed to this report.
(Bloomberg) -- A personalized vaccine developed by Merck & Co. and Moderna Inc. helped prevent the recurrence of severe skin cancer for three years in promising new results from a study.
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Patients with severe melanomas who got the vaccine and Mercks cancer drug Keytruda were 49% less likely to die or have their cancer return than those who got Keytruda alone, the companies said Thursday.
The findings are especially important for Moderna, the Covid shot-maker whose post-pandemic strategy involves developing new uses for its messenger RNA technology to fight flu, RSV and cancer. Last month, Moderna said it expected revenue to fall sharply in 2024 to a level well below analysts expectations, sparking concerns about the companys ability to pay for its ambitious product pipeline.
Read More: Merck-Moderna Vaccine Helps Keep Patients Free From Skin Cancer
Melanoma accounts for only about 1% of US skin cancers, but causes most of the annual deaths from the disease. Making the cancer vaccine involves analyzing the genetic sequence of each patients tumor to create a personalized therapy that teaches the immune system to recognize markers of the abnormal growth. In the mid-stage study, patients received the drugs after the tumors were surgically removed.
Moderna shares gained as much as 21% on Thursday when the US markets opened, their biggest increase in a year. The companys stock had lost more than half its value this year through Wednesdays close. Mercks shares were down about 1%.
The three-year results are similar to those seen after two years, when the risk of death or recurrence was 44% lower among those who got the drug-vaccine combination than those getting Keytruda alone. Side effects remained generally mild, such as fatigue, pain at the injection site and chills, they said.
Story continues
Weve now answered the one remaining scientific question: Is this benefit short-lived or is it going to be durable? Moderna President Stephen Hoge said in an interview.
In July, Moderna and Merck began a late-stage trial of the combined treatment in melanoma patients. Such a trial may be necessary to confirm the results, and could take three or four years, Hoge said, though regulators may help make the treatment available to patients sooner.
In an interview on Bloomberg TV, Moderna Chief Executive Officer Stphane Bancel said the companies want to talk to regulators about getting the skin cancer vaccine approved on a faster timeline. The cancer vaccine could launch as early as 2025, Bancel said in an interview with CNBC.
If you look at the next 24 months, its going to be very dense news flow, very dense product launches, he said.
Merck and Moderna are testing the combination in other cancers where Keytruda is already used. Earlier this week, the companies said they began a late-stage trial of the combination in lung cancer patients.
--With assistance from Fiona Rutherford.
(Updates with shares in fifth paragraph.)
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This story is part of Natures 10, an annual list compiled by Natures editors exploring key developments in science and the individuals who contributed to them.
In October, work and life collided for Halidou Tinto when his six-year-old daughter caught malaria. A director of clinical trials for malaria drugs and vaccines for more than a decade, Tinto knew how severe the disease could be. His daughter was hospitalized for four days with a fever, headaches and vomiting. She recovered, but it was really serious, he says.
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That same month, a vaccine called R21 that he had been testing was recommended for use by the World Health Organization (WHO). It is only the second malaria vaccine to be approved and many think it could prevent millions of deaths in Africa, where the vast majority of malaria infections occur. Every year there are more than 200 million cases and 500,000 deaths on the continent, predominantly in children younger than 5 years old.
The institute that Tinto directs, the Clinical Research Unit of Nanoro (CRUN) in Burkina Faso, is a key test site for R21, its predecessor RTS,S and several other drugs. Many scientists credit Tintos diligence for the institutes success.
Tinto earned a PhD at the University of Antwerp in Belgium, studying how malaria becomes resistant to various drugs. His adviser at the time, Umberto DAlessandro, a clinical epidemiologist now at the London School of Hygiene & Tropical Medicine and based in Fajara, the Gambia, says that he has always been struck by both Tintos rigour as a scientist and his dedication. He truly wants to advance science and research in Africa, says DAlessandro.
Tinto had an opportunity to do a postdoc at a US university, but turned it down to return to Burkina Faso in 2006. There, he helped to establish the CRUN with local scientists and clinicians.
In 2007, pharmaceutical company GSK and its partners were gearing up to do late-stage clinical trials of RTS,S a vaccine that had been in development for years. For Tintos new clinic, with just ten employees, becoming part of the trial seemed like a long shot. They were surprised that we applied, he says, because there was no electricity, no cars, nothing. Nevertheless, Tinto convinced the coordinators that he could make it work.
He met with the king of the village, and together they persuaded the Burkina Faso government to connect Nanoro to the national grid. The CRUN produced data that helped to get RTS,S approved in Africa.
That vaccine has been associated with a significant reduction in child mortality. But GSK can produce only a few million doses a year. Even if Burkina Faso got one million of those, Tinto says, that would vaccinate only 250,000 children a year. We still have millions of children lagging behind, he says. Thats why people are excited about R21: the Serum Institute of India in Pune can currently produce 100 million doses a year. R21 should also be more affordable than RTS,S, and some researchers expect it to be more effective.
Tinto ran an influential early study of the vaccine, starting in 2019 (M. S. Datoo et al. Lancet 397, 18091818; 2021). He led the trial that really, to people in the field, showed that this vaccine was going to be different, says Adrian Hill, a vaccinologist at the University of Oxford, UK, who oversaw the development of R21.
The WHO has said that R21 will be available across Africa as early as mid-2024. Meanwhile, Tinto is working on more than 30 clinical trials, including two further malaria vaccines and more studies on R21.
CRUN has expanded beyond Nanoro, and now has more than 400 staff members and associates, including dozens of graduate students from all over Africa. DAlessandro, with whom Tinto still collaborates, says that it is a good example of how research can stimulate development in Africa. But what inspires Tinto the most is the opportunity to save lives. You cannot have really any other satisfaction beyond that; because life, for me, is the most important thing.
Using Tuesday to announce good newsthat its $43 billion acquisition of Seagen would be finalized on ThursdayPfizer sandwiched its bad news, which came on Wednesday with its 2024 guidance.
The company expects (PDF) revenue to reach between $58.5 billion and $61.5 billion next year, coming up short of the analyst consensus of $63.2 billion, largely because of the plummeting demand for its COVID-19 products.
With the update, Pfizers shares had fallen by 9% by mid-morning. Other COVID product manufacturers saw a slide as well. Shares for Pfizers vaccine partner BioNTech dropped by 5%, while the price for Modernas stock also fell by 5%.
The new figures for Pfizer continue a trend. This year, the company twice had to slash its revenue forecast for 2023, largely because it didnt foresee COVID-19 product demand falling so precipitously. In reporting its third-quarter revenue in October, Pfizer slashed its 2023 revenue forecast by a whopping $9 billion.
Pfizer now estimates combined sales of its COVID Comirnaty vaccine and Paxlovid pill to reach $8 billion in 2024. In 2022, the products combined for sales of $57 billion. This year, they are projected to reach $12.5 billion, Pfizer said in October.
Pfizer is deliberately shooting low on its COVID product estimate, even though CEO Albert Bourla said during a conference call on Wednesday that the company expects vaccination and treatment rates next year to match those of this year.
We want to be conservative and are giving a good floor, Bourla said. We want to be reliable so that we will not create again uncertainty, which was the case early this year when our estimates were way higher than in reality.
Pfizer also said that Seagen will contribute an estimated $3.1 billion to the top line in 2024. Propelled by its leadership in antibody-drug conjugate R&D, the Seattle biotech is rapidly growing, evidenced by its revenue figure in 2022 of $2.0 billion. The company stopped providing guidance this year, following its deal with Pfizer, which was revealed in March.
Pfizer also said that it is expanding its cost-realignment program, from $3.5 billion to $4 billion in 2024. CFO Dave Denton said that 70% of the program will impact R&D investment, while 30% will come from SIA (selling, information and administrative) costs.
Aside from its COVID products, Pfizer has in the past projected its non-COVID compound annual growth rate from 2020 to 2025 to be 6%. But Denton admitted that the figure would be very challenging to meet, given the 2024 guidance.
We still feel very strongly about the products that we have in the marketplace. They continue to grow nicely. Our launches continue to grow well, Denton said But I think that 6, excluding (business development), is a more aggressive target at this time given what has happened.
So far this year, Pfizer's share price has dropped by nearly 49%. The company's shares are now trading at a price lower than before the pandemic elevated Pfizer to a global biopharma star.
