FPM statement on COVID-19 vaccine dosing regimen and roll-out
Posted on: Thursday 28 January 2021
Author: FPM
- The Faculty of Pharmaceutical Medicine (FPM) welcomes the collaboration between the pharmaceutical industry, academia, clinicians, charities, the NHS and the public in developing vaccines contributing towards a solution to the COVID-19 pandemic.
- The Commission on Human Medicine (CHM), Joint Committee on Vaccination and Immunisation (JCVI) and Medicines and Healthcare products Regulatory Agency (MHRA) have reviewed the public data and the technical dossiers on two COVID-19 vaccines (the BioNTech /Pfizer and Oxford/AZ vaccines), and have formed recommendations based on these data. It is their considered opinion and made in the interests of public health.
- FPM recognises that there may be disagreement between experts on the analysis and the recommendations. FPM notes that it is the competent bodies’ responsibility in particular the JVCI to advise on the emergency use of these two vaccines on behalf of the nation.
- FPM recognises the difficulties of rapidly rolling out vaccines to all high risk patients, when supply is constrained.
- Pharmaceutical companies routinely expect their products to be administered in line with the clinical trial data submitted to regulatory authorities. The FPM recognises the unprecedented situation of the pandemic and accordingly understands that the available data may also need to be weighed against other public health considerations. This may influence the expert recommendations on the use of vaccines in practice.
- Pharmaceutical companies have a responsibility to operate a comprehensive pharmacovigilance system for their products and to continuously evaluate the benefit risk profile in conjunction with regulatory authorities.
- FPM recommends ongoing active monitoring of the roll-out with collaboration between all stakeholders as recommended by the WHO. The PHE COVID-19 vaccine surveillance strategy is one key aspect, together with ongoing monitoring by companies and by the MHRA. It is particularly important to learn about the impact of vaccines on transmissibility of the virus.
- FPM notes that principles of maintaining patient trust and of obtaining valid consent prior to any medical intervention, remain critically important during a public health emergency.
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