Peter C Gøtzsche of the Institute for Scientific Freedom, and Karsten Juhl Jørgensen of the Cochrane Collaboration, have published their analysis of The European Medicines Agency (EMA) 2015 investigation which concluded there was no link between HPV vaccines and serious neurological adverse events, and they report that the “EMA relied on the data the drug companies had provided to them even though it had been demonstrated that the companies had underreported possible neurological harms.”
In this paper, the authors explain in detail that:
➡︎ The review was not independent
➡︎ Important independent studies were not included
➡︎ Despite claims by the manufacturers, there were no placebo-controlled trials
➡︎ The experts disagreed on the interpretation of the data
Public trust in drug regulation, including for vaccines, relies on transparency, honesty about uncertainties and adequate, unconflicted assessment of benefits and harms. EMA’s practice of leaving investigations of suspected serious harms to the manufacturers does not further public trust and should be revised.
As is the general rule for other drugs, placebo or no-treatment controls are needed in trials of vaccines in order to study the occurrence of harms before drug approval. If considered unethical for the HPV vaccines, dose–response studies could be carried out. When Merck compared its nine-valent Gardasil 9 with quadrivalent Gardasil in 14215 women, there were more serious systemic adverse events in the Gardasil 9 group (3.3% vs 2.6%, p=0.01, our calculation).22 Gardasil 9 has four more antigens than the quadrivalent vaccine and contains 500μg of the aluminium adjuvant, compared with only 225μg. The safety of the aluminium adjuvants commonly used in vaccines should be tested.
EMA should avoid using experts in its committees with conflicts of interest and should make available all reports on its website, including those used for deliberations in its scientific advisory groups.
https://ebm.bmj.com/content/ebmed/early/2021/01/28/bmjebm-2020-111470.full.pdf
