Already complicated to keep, the promise of the President of the Republic of a second wave of vaccination between April and June 2021 for “ the biggest number »Seems to have lead in the wing after the announcements of Sanofi, Friday December 11th.
Not effective enough in the elderly
Associated with the British GSK, which supplies the adjuvant, the French pharmaceutical giant explained that its vaccine would not be ready before the end of next year, due to less good than expected results during the second phase of trials clinics.
[#COVID19] @sanofi announces the interim results of phase 1/2 of the vaccine candidate developed with @GSK. Driven by science, we remain confident in our efforts despite a delay in the clinical trials process. Read the press release ⤵️https: //t.co/Mr9Et7LQcN
– Sanofi France (@SanofiFR) December 11, 2020
” In adults aged 18 to 49 years, interim results from the Phase I / II study showed an immune response comparable to that of patients who recovered from COVID-19 infection, but a weak immune response in older adults, potentially due to an insufficient concentration of antigens “, Say the two groups. The study was conducted in the United States on 441 adults.
Sanofi and GSK now plan to launch another phase of testing from February, relying in particular on an experiment carried out on “non-human” primates with a new formulation of antigens. She showed that “The vaccine candidate could confer protection against pulmonary pathologies and lead to rapid elimination of the virus from the nasal passages and lungs within 2 to 4 days”, underlines the press release.
All the calendar is to be reviewed
If the results of these tests are positive, phase III, that is to say that which is carried out on a larger scale (30,000 people), could start in the second trimester. Authorization requests would be made in the second semester, ” which will have the effect of postponing the potential availability of the vaccine to the fourth quarter of 2021 “. Initially, Sanofi planned to distribute 1 billion doses in 2021, including 300 million doses in Europe.
Sanofi was to make its first deliveries at the end of June, but hoped to be able to do so a little earlier. The factories were ready and production was even due to start in the coming weeks, when phase III was launched. “ The goal is still to start large-scale production as soon as the optimized formulation is defined, at the end of phase IIb », Assures a spokesperson for the group.
The race for mass vaccination
This is a severe blow for Sanofi, which has already fallen behind its competitors. ” But the vaccine race is long and the first will not be the winner who will take the stake. Vaccination campaigns will last for several years and around the world “, Tempers Marie Humblot-Ferrero, associate director at BCG.
→ EXPLANATION. What we know about the risks of Pfizer’s vaccine
The setbacks of the French laboratory show in any case how the mass vaccination schedule is likely to be extremely tight in Europe next year, although the European Commission has reserved 1.5 billion doses from large laboratories.
The first two vaccines, those from Moderna and Pfizer, whose production will gradually increase in Europe, will not be delivered in large quantities, at least for the time being. Governments therefore relied on the large volumes announced by Sanofi-GSK, Janssen and AstraZeneca. They can now only count on the last two.
The cards are reshuffled
AstraZeneca, associated with the Oxford laboratory, has just seen its results validated in the scientific journal Lancet, but its vaccine is only effective at 70% on average. At the end of November, the Swede had to launch an additional study due to differences in results linked to differences in dosages. This had raised some doubts, to the point that some wondered if this would not lead the European Medicines Agency to postpone its marketing authorization, scheduled for before December 29, until later.
→ READ. Anti-Covid vaccine: why 200 million doses for 67 million French people?
Last twist, AstraZeneca and Russia announced Friday, December 11, that they would launch joint clinical trials combining their two vaccines, in order to ” generate greater protection ”. They should start before the end of the year. According to Russia, its Sputnik V vaccine is 95% effective. It is currently in phase 3 of clinical trials with more than 40,000 volunteers, but it has already started to be distributed to the population.