Drug regulators have cleared a Pfizer vaccine to fight the human coronavirus (HCV), causing the global spread of meningitis B, in young children. The FDA also recommended the use of two other vaccines to help protect pregnant women from the respiratory virus that causes cervical cancer.
The manufacturer, Pfizer Vaccines, made the three vaccines as a part of a blockbuster contract with US health authorities in 2008. Since then, the number of severe cases of meningitis B, also known as chronic myelogenous leukaemia, have spiked in children around the world. To fight it, Pfizer developed a vaccine that caused an artificial form of antibodies to be produced.
All three vaccines have been approved for use in adults and adults with weakened immune systems.
In a review of the overall safety of the vaccines, the US Food and Drug Administration (FDA) found that there were cases of serious or sometimes fatal inflammation of the heart in newborns after taking the vaccine. One case of a serious inflammation of the liver was also reported. The analysis was conducted by scientists from the National Institutes of Health (NIH) who reviewed 12 cases.
In a statement, the FDA said its review “did not identify any increase in serious adverse events in children compared to children receiving a placebo.”
A placebo is an inactive substance given to people to test their reactions to new or different treatments, such as medicine. But the FDA stressed that its analysis showed no evidence of any “serious adverse events” occurring in the children, including those taking the vaccine, because of meningitis B.
The FDA said there were more deaths in adults taking the vaccine compared to the placebo group. In the report, the FDA said that the deaths were “extraordinarily rare” and occurred with one exception out of 83 vaccine-related deaths observed. It said one death in adults was associated with an immune problem caused by the antigens in the vaccine. The four other deaths were related to the immune system.
In its analysis, the FDA said that a vaccine given to young children would be “the primary target market” for the corona virus. The US government had estimated in 2008 that some 575,000 children worldwide would be vaccinated under the contract signed with Pfizer.
“The three certified vaccines now in use provide important protection for persons at high risk of complications of meningitis,” said Keith Wiese, MD, director of the FDA’s office of unapproved new drugs and biological products.
Although many people are exposed to the infection, experts say protection is limited for some as the infection is on the order of a common cold.
“Meningitis B is a common illness, but without treatment many victims have some vision loss, or shock, sometimes require a blood transfusion and even die,” said Bruce Greene, MD, Pfizer Vaccines chief medical officer.
The FDA said that the vaccine, which is injected as a single needle, is “non-invasive and safe for children, particularly those with other health issues.”