French health authority, the Haute Autorité de Santé (HAS), has approved AstraZeneca’s Covid-19 vaccine, but has recommended that it be used, for now, only for people under 65 and health- and care-sector professionals, due to a lack of data of its efficacy among older age groups.
It is the third Covid vaccine to be approved in France after those of Pfizer-BioNTech and Moderna.
The AstraZeneca vaccine can be stored at higher temperatures than those of Pfizer and Moderna, making it easier to deploy.
Dr Alain Fischer, the official coordinator of France’s vaccination campaign, said that the AstraZeneca vaccine will be available in France around the middle of February.
The HAS gave its approval yesterday (February 2), describing its effectiveness as “satisfactory” - between 62% and 70%.
“The HAS considers that this vaccine has its rightful place in the vaccination strategy in the context of active circulation of the virus and a worrying evolution of the epidemic,” it wrote in a press release.
That rightful place for the moment will be vaccinating the under 65s, beginning by those with underlying health issues.
This means that the vaccine will likely be used by the government only for phase 3 of its planned vaccination rollout.
This phase involves vaccinating the entire population, beginning with people aged 50 to 65.
The government had originally planned to begin this phase at the end of June, but it could now be brought forward.
AstraZeneca for the under 65s?
The HAS stated that, “due to the small number of participants aged 65 and over in the trials, it is not possible to conclude on vaccine efficacy in this population”.
“In this context, and in order to speed up the vaccination campaign, the HAS recommends using the AstraZeneca vaccine in people under the age of 65, starting with professionals in the health or medico-social sector, whatever their age, and people aged between 50 and 64 with co-morbidities,” the authority stated.
The HAS stated that their recommendation "will be re-examined in light of the availability of additional data, particularly for persons aged 65 and over."
MP Jean-Christophe Lagarde has called for the AstraZeneca vaccine to be given to higher education students as a priority. The HAS did not mention this in its review of the vaccine.
Meanwhile Elisabeth Bouvet, president of the technical commission on vaccinations at HAS, said, “it seems crucial to us in the current situation that front-line health professionals be protected in a significant way”.
The government has not yet stated if and how it will implement the HAS’s recommendations, so there are no further details on how the AstraZeneca vaccine will be used.
President Emmanuel Macron said yesterday that by the end of summer, “we will have offered the vaccine to all French adults who wish to have it”.
D'ici à la fin de l'été, nous aurons proposé à tous les Français adultes qui le souhaitent un vaccin.— Emmanuel Macron (@EmmanuelMacron) February 2, 2021
“What constrains us today in the vaccination campaign is access to the doses. We have a calendar. Between the end of February and the beginning of March, four French sites will produce the vaccine. Our mobilisation remains total,” he Tweeted.
Doses between 9 and 12 weeks apart
The HAS has recommended that the two doses of the AstraZeneca vaccine be delivered to patients between nine and 12 weeks apart.
“In the trials, the second dose was administered between 4 and more than 12 weeks after the first. The available efficacy data suggest that vaccine efficacy increases when the time between the two doses is extended,” The HAS stated.
“The HAS recommends a nine to 12 week interval between the two doses of the AZD1222 vaccine developed by AstraZeneca. In all cases, the administration of the second dose of the vaccine remains absolutely necessary.”
In France, the second dose of the Pfizer-BioNTech Covid vaccine is administered between three and four weeks apart. The HAS had recommended extending this gap to six weeks, but health minister Olivier Véran ruled it out.
Mr Véran said he had “chosen the safety of validated data” in reaching the decision, which keeps France in step with the recommendation of producers Pfizer-BioNTech.
The two doses of the Moderna vaccine, meanwhile, should be administered four weeks apart, but that can be extended to six weeks.
The UK government is allowing for a gap of up to 12 weeks between doses for all three of these vaccines.
Pharmacists to administer AstraZeneca vaccine
Unlike the Pfizer-BioNTech and Moderna vaccines that have to be stored at very cold temperatures, the AstraZeneca one can be kept between 4°C and 8°C.
The HAS stated that this makes it possible to administer outside of a Covid vaccination centre setting.
“The aim is to diversify the profile of vaccinators, increase their number and multiply the number of vaccination sites,” the HAS stated.
“Thus, in addition to doctors and nurses, the HAS is now recommending that midwives and pharmacists already trained in administering vaccinations… should be able to prescribe and administer the AstraZeneca vaccine.”
The government’s spokesperson, Gabriel Attal, has already said that pharmacists will be able to administer the AstraZeneca vaccine.
The head of the pharmacists union the Fédération des syndicats pharmaceutiques de France (FSPF) told Franceinfo that the vaccine will be in pharmacies by the third week of February.
Dr Jean-Paul Hamon, honorary president of the Fédération des Médecins de France doctors’ union, has said he is “a little annoyed” by the idea of pharmacists administering the vaccination.
He said that when delivering the first dose of a vaccine that has arrived on the market, a doctor should be present to ensure safety.
“I still think that you have to have a minimum of caution and at least a minimum of training and teach pharmacists and midwives how to manage anaphylactic shock,” he told Franceinfo.