France's top health authority has formally approved the Pfizer-BioNTech Covid-19 vaccine, giving the green light to the nationwide inoculation campaign that is to start on 27 December. However, the Haute Autorité de la santé (HAS) says some questions remain.
The vaccine against Covid-19 developed by US drug producer Pfizer and Germany's BioNTech, "can be used in people 16 years of age and over" according to HAS, which points out that effectiveness and high tolerance among the population is “satisfactory”.
The vaccine, christened "Comirnaty", was approved for France and the EU by the bloc's health regulator, the European Medicines Agency (EMA) earlier in the week. The procedures have now been rubber stamped by HAS.
First in line are those at risk: the elderly, people affected by other illnesses and people who are likely to be exposed to the pandemic, such as doctors and hospital staff.
HAS says that two doses of Comirnaty applied over a period of 21 days have a “95 percent effectiveness” against symptoms of the virus, while minor side effects like pain at the place of injection, tiredness and headaches may occur.
But the authority pointed out that it is still awaiting more detailed data on how effective the vaccine will be for over 75-year-olds and under-16-year olds. It also said it was not clear how effective the vaccine would be against new mutations of the virus.
How does the vaccine work?
Comirnaty works by “preparing the body to defend itself against Covid-19”, according to EMA. It contains a molecule called messenger RNA (mRNA) which has instructions for making the spike protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body’s cells.
When a person gets a jab, some of their cells will read the mRNA instructions and temporarily produce this spike protein. The person’s immune system the wakes up, recognises the protein as foreign and starts producing antibodies and activate T cells (white blood cells) to attack it.
If the person the contracts the SARS-CoV-2 virus, his or her immune system will recognise it and will defend the body against it.
Pfizer says in a statement that the use of the vaccine in the US will be limited as it “has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorised for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older” and use can be revoke if the EUA is terminated.