Brazil approves early access to MenQuadfi vaccine for six-week-old infants to combat meningococcal disease

Brazilian health regulator Anvisa has widened the use of the MenQuadfi meningococcal vaccine, now approved for children from six weeks old, aligning with international standards and potentially enhancing early protection against a rapid-spreading infection.

Brazil’s health regulator has expanded access to the MenQuadfi meningococcal vaccine, allowing it to be given to babies from six weeks of age in a move that could strengthen early protection against a fast-moving infection.

Anvisa approved the change on Tuesday, broadening use of the shot, which had previously been indicated only from 12 months of age. The vaccine is injected into a muscle and targets meningococcal disease caused by Neisseria meningitidis groups A, C, W and Y.

The decision follows an assessment of data from more than 11,000 children. In the group of younger infants, regulators reviewed results from 6,060 children aged between six weeks and under 12 months who received one, two or three doses, alongside 5,373 participants who later received a booster dose from 12 months onwards. Anvisa said the evidence did not raise any new safety concerns and was consistent with the expected profile for conjugate meningococcal vaccines.

The change aligns Brazil with other regulators that have recently widened access to the same product. The US Food and Drug Administration says MenQuadfi is approved for active immunisation against invasive meningococcal disease in people aged six weeks and older, while the European Commission also backed an extension of use for infants from six weeks this summer. Sanofi said the European decision was based on infant data from its MET58 clinical study.

Invasive meningococcal disease can develop when the bacteria move beyond the respiratory tract and spread through the body. It is transmitted mainly through droplets from breathing, speaking, coughing or sneezing, and can progress quickly. Anvisa says the condition carries a mortality rate of about 10% even with treatment, and as many as one in five survivors may be left with lasting complications.