Panama considers fourth dose of covid vaccine for older adults
The vaccine advisors of the Ministry of Health (Minsa) are discussing applying a fourth dose of the Pfizer/BioNTech vaccine against Covid-19 to older adults.
The national secretary of Science, Technology and Innovation, Eduardo Ortega Barría, indicated that the issue has been previously discussed and they were waiting for the proposals of the FDA.
Panama approved on February 18 or a fourth dose for immunosuppressed patients over 16 years of age, three months after their third dose
Peter Marks, director of the FDA’s Center for Biological Evaluation and Research, said they have determined that the known and potential benefits of a second booster dose of the Covid-19 vaccine with any of these vaccines outweigh the known and potential risks in these vaccines.
In addition, it said that the evidence considered for the authorization of a second booster dose after primary vaccination (two doses) and the first booster dose included data on safety and immune response provided to the agency, as well as additional information on the efficiency presented by the companies.
In making the decision, the FDA relied on safety surveillance data provided by the Israeli Ministry of Health on the administration of approximately 700,000 doses (second booster) of the Pfizer/BioNTech vaccine, administered at least 4 months after the third dose in adults 18 years of age and older (about 600,000 were 60 years of age or older), and there were no safety concerns.
In the statement, the FDA also cited data from a study of 154 health care workers, whose antibody levels, including against the Delta and Omicron variants, rose two weeks after receiving the fourth dose.
The data emerged from a study published this month by Israeli researchers in the New England Journal of Medicine , which concluded that three doses of current-generation messenger RNA vaccines further boost the immune response generated. That is, three doses boost immunity levels, the fourth dose restores antibody levels to where they were shortly after the third dose.
The FDA authorization comes two weeks after both companies filed for approval of the second booster dose.