Vaxelis Combination Vaccine A New Terror For Children? No. The viral claim is false.

What is the Vaxelis vaccine? 

Vaxelis is a combination vaccine designed to protect children against six serious diseases: diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b (Hib), and hepatitis B. It is approved for use in infants and children from 6 weeks through 4 years of age. Vaxelis helps reduce the number of injections a child needs by combining multiple vaccines into a single shot. 

But recently, social media users, especially those who run anti-vaccine campaigns have raised alarm against Vaxelis. These claims highlight a past review by the Institute of Medicine, which found evidence suggesting a causal relationship between tetanus toxoid-containing vaccines and rare neurological conditions such as brachial neuritis and Guillain-Barré Syndrome—a disorder that can cause temporary paralysis. Critics also point out that in some cases, apnea (a temporary pause in breathing) has been observed in infants following intramuscular vaccination. Additionally, they claim that Vaxelis was not tested in randomized controlled trials using an inert placebo, but rather compared against other vaccines. Concerns have also been raised about the ingredients in the vaccine, including 319 micrograms of aluminum as an adjuvant, along with trace amounts of formaldehyde, bovine serum albumin, neomycin, streptomycin, and polymyxin B. Furthermore, as stated in Section 13.1 of its FDA label, Vaxelis has not been evaluated for its potential to cause cancer, genetic mutations, or fertility issues.

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Fact Check- 

Is Vaxelis a safe and approved vaccine?

According to the FDA, Vaxelis is a single shot vaccine approved by the FDA for children aged 6 weeks to 4 years to protect against Diphtheria, Tetanus, Pertussis, Polio, Hepatitis B, and Haemophilus influenzae type b. It’s given in a 3‑dose series at 2, 4, and 6 months (0.5 mL each), using a vial or prefilled syringe stored refrigerated but not frozen. Common side effects in infants include irritability, site pain, sleepiness, fever, redness, reduced appetite, swelling, crying, and vomiting which are similar to other routine vaccines. 

People having allergies, serious neurologic reactions to pertussis vaccines, or certain neurological conditions should not receive Vaxelis. It has been advised to mention any health conditions to the physician before taking the vaccine. 

As per National Center for Immunisation Research and Surveillance Australia (NCIRS), Vaxelis and Infanrix hexa are two vaccines that protect babies from six serious diseases: diphtheria, tetanus, whooping cough, hepatitis B, polio, and Hib. Vaxelis was added to Australia’s National Immunisation Program (NIP) on 1 July 2023, as another option for babies at 2, 4, and 6 months of age. Vaxelis can be given with other vaccines like Bexsero and the flu shot. 

Common side effects are mild, such as fussiness, sleepiness, fever, and swelling or pain at the injection site. These usually last only 1 or 2 days. Australia’s health authorities are monitoring Vaxelis for safety. It’s safe to give Vaxelis with other routine vaccines as well. 

A report published on Vaxelis website stated that two clinical trials on more than 3000 infants were carried across the US. The common side effects seen within 5 days post vaccinations were mild to moderate irritability in 55 percent or more of cases, crying in 45 percent or more, pain at the injection site in 44 percent or more, sleepiness in 40 percent or more, redness at the injection site in 25 percent or more, reduced appetite in 23 percent or more, fever of one hundred point four degrees Fahrenheit or higher in 19 percent or more, swelling in 18 percent or more, and vomiting in 9 percent or more of cases. According to the report, these reactions were generally similar in severity to those seen in other vaccines. 

CDC had also approved the use of Vaxelis vaccine for Diphtheria, Tetanus, and Pertussis (DTaP), Polio and Hepatitis B. A combination vaccine generally is preferred over separate injections of the equivalent component vaccines and may be used when any of the components are indicated and none are contraindicated. Switching between combination and single-component vaccine products is acceptable if the minimum intervals for all the components are maintained and follow age indications.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Vaxelis’s benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee considered that Vaxelis has been shown to produce satisfactory antibody levels against diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses and Hib. These antibody levels have been previously shown to protect against these diseases. With regard to safety, the CHMP considered that overall its safety profile is similar to other vaccines.

Fact about presence of Aluminium and other adjuvants in a vaccine: 

Aluminum salts like aluminum hydroxide have been safely used in vaccines for over 70 years. They help boost the body’s immune response and were first used in vaccines for diseases like diphtheria and tetanus. Other adjuvants have been developed to target specific components of the body’s immune response, so that protection against disease is stronger and lasts longer. All vaccines with adjuvants are tested for safety before approval and are regularly monitored by health authorities like the CDC and FDA. A recent study found a possible link between aluminum in vaccines and asthma in children. But, CDC stated that it is not changing vaccine recommendations based on this single study. 

Vaxelis has not been evaluated for its potential to cause cancer, genetic mutation as mentioned in Section 13?

According to an article, Section 13 that appears on documentation in the vaccination package has been misinterpreted and used to mislead people. Section 13 states that the vaccine “has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.” 

This means that there was no need for further testing because toxicology studies conducted at the preclinical phase showed no signs of adverse effects from the vaccine or its individual components.

Conclusion:

Fact Crescendo found the claim to be false. Vaxelis vaccine is safe and must be used as directed by a physician. All the components in the combination vaccine are being closely monitored.