SAHPRA Vaccine Approval for Adolescents Under Review

Strategic Insights -

A committee has been established to review the approval of a COVID-19 vaccine for adolescents by the South African Health Products Regulatory Authority (SAHPRA). The committee is a result of an appeal by the anti-vaccination organization Free-the-Children Save the Nation against the decision in 2021 to approve the Pfizer vaccine for teens. The Minister of Health is legally obligated to set up the committee, as stated in the Medicines Act, which allows any person aggrieved by a SAPHRA decision to appeal it.

Key Takeaways:

  • The Minister of Health has established a committee to review the approval of a COVID-19 vaccine for adolescents by SAHPRA, following an appeal by the anti-vaccination organization Free-the-Children Save the Nation.
  • The committee consists of five people, including Professors Glenda Gray and Salim Abdool Karim, who are experts on infectious disease and vaccination, and two doctors skeptical of vaccination: Herman Edeling and Stephen Schmidt, chosen by Free-the-Children.
  • The committee will be chaired by advocate Tembeka Ngcukaitobi, and the hearing will take place on February 11 and 14.
  • A ruling must be issued within 30 days of the committee's first meeting, and either party can take the ruling on review to court if they remain aggrieved.
  • The approval of the vaccine may be endangered if the ruling goes against SAHPRA, but the health department may be able to continue providing the vaccine "off-label" without SAHPRA's approval.
  • The anti-vaccination organization Free-the-Children Save the Nation has been criticized by medical experts for their pseudoscientific views on COVID-19 and vaccination.

Statistics:

  • 2021: The year in which the Pfizer vaccine was approved for teens by SAHPRA.
  • 2: The number of doctors skeptical of vaccination chosen by Free-the-Children to sit on the committee.
  • 5: The total number of people on the committee.
  • 30: The number of days within which a ruling must be issued by the committee.
  • 2: The number of experts chosen by the SAHPRA CEO: Professors Glenda Gray and Salim Abdool Karim.

Sources:

  • GroundUp
  • AllAfrica Global Media (allAfrica.com)
  • Medicines Act
  • Professors Glenda Gray and Salim Abdool Karim
  • Advocate Tembeka Ngcukaitobi