WHO greenlights mpox vaccine for babies in Africa – despite no prior clinical trials

By bellecarter // 2024-09-22

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The World Health Organization (WHO) recently approved the first mpox (monkeypox) vaccine for adults in Africa, the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine from the Danish pharmaceutical company Bavarian Nordic. According to the WHO, the approval will accelerate vaccine access for millions to reduce transmission and help contain the outbreak. "This first prequalification of a vaccine against mpox is an important step in our fight against the disease, both in the context of the current outbreaks in Africa and in the future," said WHO Director-General Dr. Tedros Adhanom Ghebreyesus. "We now need urgent scale up in procurement, donations and rollout to ensure equitable access to vaccines where they are needed most, alongside other public health tools, to prevent infections, stop transmission and save lives." They can be administered in people over 18 as a two-dose injection given four weeks apart. After prior cold storage, the vaccine can be kept refrigerated for up to eight weeks in containers of at least 46 Fahrenheit or colder. However, it was also said that the vaccine can be used for babies, children, teens and pregnant women. "While MVA-BN is currently not licensed for persons under 18 years of age, this vaccine may be used 'off-label' in infants, children and adolescents, and pregnant and immunocompromised people. This means vaccine use is recommended in outbreak settings where the benefits of vaccination outweigh the potential risks," the WHO website indicated. Moreover, the WHO Strategic Advisory Group of Experts on Immunization reviewed all available evidence and recommended the use of the said vaccine. Its Weekly Epidemiological Record report said that "MVA-BN has not been specifically studied in clinical trials in children." "The same non-replicating MVA viral vector is used as a platform for other vaccines that include MVA-filo (Mvabea™) against Ebola virus disease (EVD)," it said. "The EVD vaccine is approved by the EU for adults and children aged 1 year and older. Data from five published studies on MVA-BN as a viral vector platform for the prevention of EVD, with a total population of 52,229 children, support the favorable safety profile of the product." The authors of the study published in the BMJ presented results on MVA-BN's effectiveness in adult males but said nothing about children or pregnant women. The approval of the vaccine rollout did not sit well with vaccine activists as they questioned the safety of the mpox shots. Children's Health Defense Chief Scientific Officer Brian Hooker called the WHO's approval of the shot for infants and children in Africa "a train wreck in the making." "The safety profile is abysmal in adults (up to 2.1 percent serious cardiac events in clinical trials) and the vaccine has not been adequately tested for efficacy or safety in pediatric populations. In other words, the WHO has no idea whether it will work nor do they know how much damage it will do. The WHO has again abandoned good public health principles and waved their magic vaccine wand on the mpox outbreak," Hooker said. Public health physician and biotech consultant Dr. David Bell also criticized the WHO for overly focusing on mpox vaccines and neglecting to address broader public health issues in Africa. (Related: German doctor says monkeypox is a SCAM – it's just COVID "vaccine"-induced shingles under a different name.)

Mpox vaccines from the U.S. reach Congo

Some 50,000 doses of mpox vaccine from the United States arrived in the Democratic Republic of Congo (DRC) on Sept. 10. The first batch from the European Union reached the capital Kinshasa, the center of the outbreak one week before. The 100,000 doses of the Jynneos vaccine were donated by the EU through HERA, the bloc's agency for health emergencies. Another 100,000 were delivered over the weekend. The 50,000 doses from the U.S. will be of the same Jynneos vaccine. The next batch was said to be coming from Japan. Cris Kacita Osako, coordinator of the country's Monkeypox Response Committee said that adults in Equateur, South Kivu and Sankuru will be vaccinated first starting Oct. 2. Since the start of 2024, there have been 5,549 confirmed mpox cases across the continent, with 643 associated deaths. The cases in the DRC constituted 91 percent of all the cases. Most mpox infections in the DRC and Burundi, the second-most-affected country, are in children under age 15. The DRC issued an emergency approval of the vaccine, which has already been used in Europe and the United States in adults. For the moment, the rollout will be reserved for adults, with priority groups being those who have been in close contact with infected people and sex workers, Africa CDC Director-General Dr. Jean Kaseya said. However, the European Medicines Agency is examining additional data to be able to administer it to children ranging in age from 12 to 17, which could happen at the end of the month, HERA Director-General Laurent Muschel said. Head over to Vaccines.news for stories related to this. Watch the video below that talks about the rollout of mpox vaccines in Africa on adults and children despite not conducting clinical trials. This video is from the Midwest Information Network channel on Brighteon.com.

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Mpox vaccines from the U.S. reach Congo

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