Bavarian Nordic Tests Mpox Vaccine in 2- to 11-Year-Olds, Critics Question Safety and Need

Bavarian Nordic on Tuesday announced the launch of clinical trials for its MVA-BN mpox vaccine for children ages 2 to 11. Participants will receive two doses of the vaccine.

by Brenda Baletti, Ph.D.

Bavarian Nordic on Tuesday announced the launch of clinical trials for its MVA-BN mpox vaccine for children ages 2 to 11.

The first children have already been vaccinated. The study is enrolling participants in the Democratic Republic of Congo (DRC) and plans to include study sites in Uganda, the company said.

The trial is designed to test the safety and immunogenicity of the vaccine in children ages 2 to 11 as compared to adults. The trial is enrolling 460 children who live in endemic regions and who don’t have a history of mpox illness or vaccination.

Participants will receive two doses of the vaccine.

The MVA-BN vaccine — short for “Modified Vaccinia Ankara-Bavarian Nordic” — is a smallpox/mpox vaccine. The vaccine, marketed in the U.S. as Jynneos, is sold under different brand names in other countries.

Paul Chaplin, president & CEO of Bavarian Nordic, said, “Children remain highly vulnerable to mpox infections in the ongoing outbreak in Africa, highlighting the importance and urgency to broaden the access to effective vaccines that can be safely administered to this young population.”

Children’s Health Defense (CHD) Chief Scientific Officer Brian Hooker examined Bavarian Nordic’s clinical study plan and called it “a complete disaster.”

Hooker told The Defender:

“The investigators are comparing the results observed in the pediatric cohort to those of the adult cohort. I can’t emphasize enough the need for an unvaccinated control group of children, for any type of meaningful safety or efficacy evaluation.

“Also, the exclusion criteria for the trial will exclude many if not most of the children who will ultimately get the vaccine, including sick, immunocompromised and malnourished children. How in the heck could this ever be a fair evaluation?

“Bottom line, this is a fake trial to obtain a positive result for Bavarian Nordic.”

Dr. Meryl Nass, an internist, told The Defender the clinical trials for mpox vaccine showed evidence of myocarditis. Now, the company is running a trial that assesses the vaccine’s safety and efficacy among children based on how closely it matches that of adults, rather than on a placebo.

“This is a trick,” said Nass, who has reported extensively on mpox on her Substack. “This is a criminal way to conduct a clinical trial in order to avoid finding what you know is there, but you don’t want to find.”

Bavarian Nordic’s announcement comes less than two weeks after the World Health Organization (WHO) approved the company’s vaccine for adolescents ages 12 to 17.

Results from the new study could expand the current approval of MVA-BN to include children ages 2 and up.

Funding for the trials comes in part from the Coalition for Epidemic Preparedness Innovations (CEPI), which announced in May it had awarded Bavarian Nordic $6.5 million to support the Phase 2 trial. The Bill & Melinda Gates Foundation has provided funding to CEPI.

Trial doesn’t adequately test for potential heart issues

In August, the WHO declared mpox a global public health emergency for the second time in two years after a new strain of the virus spread from the DRC to neighboring regions.

The WHO quickly approved Jynneos for use against mpox for adults in September, stating then that the vaccine could be used for babies, children, teens and pregnant women if they are in “outbreak settings where the benefits of vaccination outweigh the potential risks.”

The WHO’s approval allowed governments and international agencies like Gavi, the Vaccine Alliance, and UNICEF, to buy and distribute the vaccine, MedicalXpress reported.

European Union regulators approved the drug for use in adolescents in September, “bolstering the case for using the shot in the 12 to 17 age group to contain an outbreak in parts of Africa,” Reuters reported.

The U.S. Food and Drug Administration (FDA) in September 2019 approved the Jynneos vaccine for adults to prevent mpox and smallpox and added it to the Strategic National Stockpile.

However, the FDA also granted an emergency use authorization for the vaccine for use in adolescents during the mpox outbreak of 2022.

The approvals went through even though, to date, no data on the MVA-BN clinical trial results for the 12-17 age group have been publicized.

The drug was developed as a smallpox vaccine in collaboration with the U.S. government. Although it hasn’t previously been tested in children as a smallpox vaccine, European regulators in 2020 approved a different version of the shot as part of a multi-vaccine regimen to protect against disease caused by the Ebola virus.

Several safety issues with the drug are indicated on the label, which reports that the drug is linked to myocarditis and pericarditis, immune system disorders, nervous system disorders and administration site issues.

“The MVA-BN mpox/smallpox vaccine is known to cause myocarditis or heart damage,” Dr. Peter McCullough, a cardiologist, told The Defender. “The highest risk individuals are adolescent or early adult males.”

McCullough said:

“I am concerned that the sponsor has not set up the study to evaluate cardiac safety with blood testing (troponin, BNP/NT-proBNP, galectin-3), ECG and cardiac imaging before and after the injections.

“Without prospective cohort data, Bavarian Nordic will not be able to conclude that the product is safe from a cardiac perspective.”

Other serious adverse events linked to the drug on its marketing website include several other cardiac issues, Chron’s disease, sarcoidosis, extraocular muscle paresis (eye muscle weakness) and throat tightness.

The drug also caused injection site pain and systemic adverse reactions including muscle pain, headache, fatigue, nausea and chills.

Data from the U.S. government’s Vaccine Adverse Event Reporting System (VAERS) as of Sept. 27 indicate 2,115 reports of adverse events related to MVA-BN, including 19 reports for people under 18.

Data collected by public health agencies on the more than 800,000 Americans who got the shot in 2022-2023 has not been forthcoming, Nass said.

Bavarian Nordic did not immediately respond to The Defender’s request for more information about the drug’s safety profile.

‘No business’ giving a dangerous vaccine to children

Mpox was first detected in humans in 1970 in the DRC, according to the WHO, and is considered endemic to countries in central and west Africa, with the number of cases periodically rising and falling.

The disease causes flu-like symptoms and pus-filled lesions. It is usually mild but can be serious, particularly in people with weakened immune systems, Reuters reported.

Dr. David Bell, a public health physician and former WHO scientist, criticized the global focus on mpox and mpox vaccine development at the expense of addressing broader public health issues in Africa.

For example, about 40,000 children have died from malaria in DRC this year, with similar numbers of people dying from malnutrition, tuberculosis and HIV/AIDS. Those numbers “obviously dwarf” the number of mpox deaths, Bell said.

Nass said that given the relatively minor threat posed by mpox, “There’s absolutely no reason for them to conduct a trial in children or license it for children. It’s not killing anybody. It’s not making people really sick for weeks on end.”

“They have no business giving what they know is a dangerous vaccine to children,” she added.