Filenews 30 December 2020
The second dose should be taken within three months of the first recommended by the British officials involved in the oxford vaccine approval process.
This proposal makes it clear that the Oxford vaccine differs from Pfizer's as according to the first data these doses of the vaccine do not take place within three weeks, as in the case of Pfizer.
Of course this is the assessment of the British committee and may not apply to the rest of Europe if the EMA decides or proposes otherwise.
In particular, the official involved in the process of approval of the vaccine by the UK regulator said that the AstraZeneca/Oxford vaccine can be up to 80% effective when it is three months between the administration of the first and second doses.
"Efficiency is high, up to 80%, when three months elapse between the first and second dose, which is why we made this recommendation," said Munir Pirmohamed, chairman of the Working Group of the Human Medicines Commission.
"We also looked at the half-dose protocol, which got a lot of publicity, but we felt that its results have not been proven through full analysis," he said during a press conference presenting the positive opinion of the British regulator (MHRA).
Another British doctor in charge of Covid-19 at the Joint Committee on Vaccination stated that one dose of astraZeneca/Oxford vaccine is approximately 70% effective 21 days after and before the second dose.
"In the data provided to us, and I am not sure they are published in their entirety, the efficacy was calculated between the 22nd day after the first dose and the day of administration of the second dose and the result is around 70%," Wei Shen Lim said at the same press conference.
Procedure-express for the approval of the vaccine
It is recalled that the United Kingdom again becomes the first country to approve the use of a vaccine. It was preceded by the Pfizer/BioNTech vaccine, which launched the British vaccination campaign early.
The characteristics of the AstraZeneca/ Oxford vaccine
The AstraZeneca/Oxford vaccine was long awaited for practical reasons. It is cheaper than the Pfizer/BioNTech vaccine and can be maintained at the temperature of a common refrigerator, i.e. at 2-8 degrees Celsius, which facilitates vaccination on a large scale.
The Announcement of the Ministry of Health on the approval of
The UK is one of the most affected countries, with more than 71,500 deaths, the recent outbreak, the oversaturation of the health system and large sections of the population living in lockdown conditions.
The UK regulator's green light "follows rigorous clinical trials and an in-depth analysis of the data by MHRA experts, who have concluded that the vaccine meets strict safety, quality and efficacy requirements," the British Department of Health announced.
The vaccine will be used from 4 January in the UK, which has ordered 100 million doses.
Hope to remove lockdown in new vaccine
The stakes are very serious for Boris Johnson's government, which is hesaly criticised for its management of the Coronai crisis.
In the face of the great contagiousness of the new mutation of the virus, vaccination represents the government's main hope of removing the local lockdown that has exhausted the population and torpedoed the British economy.
The variations and the mix-up with the doses
The AstraZeneca/Oxford vaccine is based on inactivated adenovirus of the common cold, isolated in chimpanzees and genetically modified. The way in which it transmits genetic material to cells with the command to attack SARS-CoV-2 was presented as the "Trojan Horse".
In the interim results of clinical trials, the British laboratory announced in November that its vaccine has an average efficacy of 70%, compared with 90% of Pfizer/BioNTech and Moderna vaccines.
However, this average concealed great differences between protocols:
efficacy at the time was 90% for volunteers who received as an initial half dose and then a whole second dose a month later. But it goes down to 62% when vaccination is done with two whole doses.
These results were criticised because half a dose was given to a group of volunteers by mistake and the limited number of volunteers who followed this second protocol forced the company to initiate additional clinical studies.
The protocol adopted today by the UK regulator provides for the administration of two whole doses.
Professor Andrew Pollard today assured the BBC that there is very strong evidence to support this method. "But, in the end, the effect of the vaccine will be achieved when it is administered to people's arms," he added
Andrew Pollard also has "no evidence" that the vaccine approved today "is not effective in the face of the new mutation of the virus."
Source: RES-BE
