Examples of Outcome Reporting Bias in Vaccine Studies: Illustrating ...

U.S. To End Vaccine Funds For Poor Countries

The Trump administration intends to terminate the United States' financial support for Gavi, the organization that has helped purchase critical vaccines for children in developing countries, saving millions of lives over the past quarter century, and to significantly scale back support for efforts to combat malaria, one of the biggest killers globally.

The administration has decided to continue some key grants for medications to treat H.I.V. And tuberculosis, and food aid to countries facing civil wars and natural disasters.

Those decisions are included in a 281-page spreadsheet that the United States Agency for International Development sent to Congress Monday night, listing the foreign aid projects it plans to continue and to terminate. The New York Times obtained a copy of the spreadsheet and other documents describing the plans.

The documents provide a sweeping overview of the extraordinary scale of the administration's retreat from a half-century-long effort to present the United States to the developing world as a compassionate ally and to lead the fight against infectious diseases that kill millions of people annually.

The cover letter details the skeletal remains of U.S.A.I.D. After the cuts, with most of its funding eliminated, and only 869 of more than 6,000 employees still on active duty.

In all, the administration has decided to continue 898 U.S.A.I.D. Awards and to end 5,341, the letter says. It says the remaining programs are worth up to $78 billion. But only $8.3 billion of that is unobligated funds — money still available to disburse. Because that amount covers awards that run several years into the future, the figure suggests a massive reduction in the $40 billion that U.S.A.I.D. Used to spend annually.

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Every Third Tablet Consumed Globally Is Manufactured In India; Work On For First Indigenous HPV Vaccine

Did you know that every third tablet consumed globally is manufactured in India? Yes, you heard that right. India's pharma sector has achieved tremendous success in the past several years.

Here are the key achievements:

India has emerged as a global hub for affordable, high-quality medicines, ranking 3rd in pharmaceutical production by volume and 14th by value.

India developed the world's first DNA vaccine for COVID-19, showcasing innovation in global health.

Produces 65% of the world's vaccines, significantly benefiting low- and middle-income countries.

The "Make in India" initiative is reducing dependency on imported Active Pharmaceutical Ingredients (APIs) through strengthened domestic manufacturing.

The Pharma industry has transitioned from a generic-focused model to developing biopharmaceuticals and biosimilars.

India is working on the first indigenous HPV vaccine to prevent cervical cancer in adolescent girls.

Key Takeaways

India's bioeconomy has grown from $10 billion in 2014 to $165.7 billion in 2024, with a target of $300 billion by 2030.

The sector contributes 4.25% to GDP with a compound annual growth rate (CAGR) of 17.9% over the past four years.

This exceptional expansion reflects the nation's focused efforts to position biotechnology as a cornerstone of sustainable economic growth and innovation. Contributing 4.25% to the national GDP, the sector has demonstrated a robust compound annual growth rate (CAGR) of 17.9% over the past four years, reinforcing India's emergence as a rising global force in biotechnology.

The bioeconomy is the use of renewable biological resources to produce food, energy and industrial goods, which supports sustainability and economic growth.

New Data On Mpox Vaccine Effectiveness

A study at Charité -- Universitätsmedizin Berlin has found that a single dose of the Imvanex vaccine provides protection against Mpox with 84% effectiveness. For people with HIV, however, a single dose of the vaccine fails to offer sufficient protection. All at-risk groups, and people with HIV in particular, should therefore receive the second dose of the vaccine as recommended. The results of the study have now been published in The Lancet Infectious Diseases.

Since a wave of infections with the Mpox virus swept around the world in 2022, Germany's Standing Commission on Vaccination (STIKO) has recommended that people at an elevated risk of Mpox infection receive an Imvanex vaccination. Originally developed to protect against smallpox, the European Medicines Agency (EMA) approved Imvanex for use to protect against Mpox in July 2022 in response to the public health emergency. The Mpox virus is related to the original smallpox virus (Variola major). The EMA's decision to approve Imvanex was based on laboratory data showing that the vaccine offers cross-protection. Until now, however, the extent of this protective effect was not clear, especially for at-risk groups.

Comprehensive study with over 9,300 participants

The EMA commissioned a team led by Prof. Leif Erik Sander, Director of the Department of Infectious Diseases and Critical Care Medicine at Charité and a research group leader at the Berlin Institute of Health at Charité (BIH), to conduct a comprehensive study into the vaccine's effectiveness against Mpox. This study compared effectiveness in people with and without HIV for the first time. "Our results confirm that a single dose of the vaccine provides good protection against Mpox, at least for a short time," says Sander. "However, this only applies to people not living with HIV. Unfortunately, we found that people with HIV -- even those taking adequate medication -- are not sufficiently protected by a single dose."

Conducted between July 2022 and December 2023, the study examined over 9,300 men and trans people who reported to have sex with changing men or trans people. These are among the groups for which STIKO recommends vaccination. Half of the study participants received a single dose of the Imvanex vaccine, while the other half remained unvaccinated. Both groups were monitored for two months on average to determine how many participants contracted an Mpox infection.

One dose protects those with a healthy immune system

Far fewer Mpox cases were recorded for HIV-negative participants in the vaccinated group than in the unvaccinated group, with the vaccine achieving 84% effectiveness. "That is a very good figure, which is likely increased even further by the second vaccine dose," says Sander. However, due to the significant drop in infections in the second half of 2022, the study was unable to determine the additional effect of a second vaccine dose.

By contrast, for people living with HIV, the study only identified a small, statistically insignificant protective effect. "The reason is presumably that developing immune protection after vaccination requires specific immune cells called T cells," explains the infectious disease expert. "These T cells often appear at lower levels in people with HIV and are not fully functional, which translates to a weaker immune response. This also corresponds to our observation that these participants experienced fewer local and systemic side effects after receiving the vaccine."

Two vaccine doses recommended for all, especially for people with HIV

"We assume that people living with HIV develop protection against Mpox after the second vaccine dose, and urgently advise these people to receive the two vaccine doses recommended by the STIKO," emphasizes Prof. Florian Kurth. Head of the Clinical Infection Research Group at Charité, Kurth played a leading role in the study alongside Sander. "We recommend that people in all other at-risk groups also complete the two-dose regimen. The immune system typically develops longer-lasting immune protection when exposed to the vaccine on more than one occasion." Further studies will be required to determine the precise extent of the protective effect in different groups following two vaccine doses.

The research team observed that vaccinated participants who still contracted the virus experienced milder symptoms. They developed fewer pox lesions, which also healed more quickly, and were less likely to report signs of systemic disease such as fever. "We assume that the second vaccination further reduces the manifestation of such symptoms," says Kurth. "Fewer pox lesions presumably also reduces the risk of transmitting the virus. Full vaccination should therefore ward off Mpox outbreaks."

Subjects tolerate vaccine well

The researchers also examined the tolerability and safety of the Mpox vaccine in over 6,500 people. The most common reaction reported was pain around the injection site. Less than 3% of vaccinated participants reported more pronounced symptoms, such as fever, headache, muscle pain, nausea or diarrhea. "The Mpox vaccine is, therefore, safe and well tolerated overall," summarized Kurth. "It is important to note that immune protection develops fully around 14 days after vaccination. In addition, people should take general preventive measures, such as using condoms -- including to protect against other sexually transmitted diseases."

The results on vaccine protection relate to clade IIb of the Mpox virus, which circulated in Germany during the study period. However, clade IIb is closely related to clade I, which is currently rampant in Central Africa and neighboring regions, so the researchers expect a very high level of cross-protection. Consequently, the results of this study could also be relevant for the current clade I outbreak in Africa. It remains unclear how long the protection from the vaccine lasts. In the next stage, the research team plans to conduct long-term studies and investigate the effects of a third vaccine dose.

About Mpox

Mpox (known until 2022 as monkeypox) is an illness caused by the monkeypox virus, which is related to the human smallpox virus. Its symptoms are similar to those caused by smallpox, which was eradicated in 1980. While smallpox was a life-threatening disease, Mpox generally runs a milder course. People typically experience fever, headache, muscle pain, back ache and swollen lymph nodes. After a few days, pustules appear on the skin and mucous membranes. These pocks can be extremely itchy and painful. Mpox-related deaths are very rare and primarily occur in children and immunocompromised people. Nevertheless, a severe bout of the disease can result in pronounced scarring and long-term harm. The Mpox virus is transmitted through close physical contact.

About Mpox infection rates

Due to genetic variations, the Mpox virus is classified in groups known as clades. In May 2022, there was a global outbreak of clade IIb, with the virus spreading primarily through close physical contact and sexual contact. Since then, over 100,000 cases have been recorded across 122 countries. While infection rates in Europe have fallen considerably since the autumn of 2022, a number of countries -- such as the USA, Brazil and Argentina -- exceeded 1,000 recorded cases in 2024, some to a significant extent. New clade IIb cases were recently reported in Australia, South Africa and South America. In addition, increasing numbers of clade I Mpox infections (including a new Ib variant) have been recorded in Africa since 2023, especially in the Democratic Republic of the Congo. In 2022, the World Health Organization (WHO) declared the clade II outbreak a public health emergency of international concern (PHEIC), followed by a corresponding declaration for the clade I outbreak in 2024.

About the Mpox vaccine

Germany's Standing Commission on Vaccination (STIKO) recommends vaccination against Mpox with Imvanex, a vaccine approved in the EU. It was approved for use against smallpox in 2013 and for use against Mpox in July 2022. It has been approved for use against Mpox in the USA and Canada for several years under the names Jynneos and Imvamune. It is a live-attenuated vaccine that contains viruses incapable of replicating in the human body. The vaccine is based on a weakened cowpox virus (modified Vaccinia virus Ankara, MVA vaccine), which serves as a sort of prototype pox virus and can thereby induce cross-protection against other pox viruses. The vaccine is recommended for groups including men aged 18 and over who have sex with men and frequently change their sexual partner, as well as laboratory personnel who work with infectious Mpox samples. Basic immunization consists of two vaccine doses.

About the study

The study was divided into two study arms to examine the tolerability and effectiveness of the Mpox vaccine. In the study arm examining safety and tolerability, researchers prospectively examined and regularly surveyed roughly 6,500 people. In the study arm examining effectiveness, researchers applied a rolling cohort design in an emulated target trial. Retrospective comparison of data on over 9,300 vaccinated and unvaccinated subjects with comparable demographic and clinical characteristics simulated a randomized clinical trial. Across all participants -- with and without HIV -- the average effectiveness of the vaccine stood at 58%. This study was funded by the BIH and the EMA.

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