(Reuters) – India ‘s drug regulator on Sunday granted final approval for the use of a two – dose coronavirus vaccine, COVISHIELD, developed by AstraZeneca and Oxford University. The regulator did not discuss the recommended times between shots.
Authorities in Britain, the first to approve the COVID-19 vaccine, on Wednesday recommended the first dose be given immediately and after the second injection four to 12 weeks later.
The differences in results are explained below.
ASTRAZENECA-OXFORD
DOSAGE:
The late AstraZeneca trial was designed for two injections four weeks apart.
But in late test data published in the Lancet on Dec. 12, the company said most participants were delayed in getting a second look.
The median time between two normal doses in UK volunteers was around 10 weeks, and six weeks in Brazil, he said.
EFFECTIVENESS:
In end-of-term trials, most participants in the UK and Brazil were given two full doses and were shown to be 62% effective – but a smaller group of volunteers with an accident received a half-dose and full dose thereafter, and recorded 90% Efficacy. They were in Britain and under 55 years of age.
Many regulators set 50% as the minimum efficacy level, but Pfizer-BioNTech and Moderna vaccines achieved more than 90% in their tests.
AstraZeneca said last month they did not know why the level of efficiency was higher, but were preparing further tests to determine if the half-dose regiment could be 90% effective.
One single dose was seen as 64% effective.
UK REGULATION
DOSAGE:
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a two-dose regimen.
The Joint Committee on Vaccination and Vaccination has recommended that people receive a single dose and then four to 12 weeks later in an effort to speed up the vaccination program.
EFFECTIVENESS:
On Wednesday, authorities dispelled one skepticism raised by AstraZeneca-Oxford data, saying a 90% success rate for half-dose and full-dose was not followed up for analysis.
The vaccine can be 80% effective when there are three months between shots, said an official involved in approving the vaccine in Britain at a briefing, higher than the average found by the vaccine. self-improvement.
Later in the same meeting, a British scientist involved in vaccine approval said that a single dose of the vaccine is about 70% effective after 21 days and before the second dose is given.
Wei Shen Lim, chair of the COVID-19 vaccination of the Joint Committee on Vaccination and Vaccination, said the data for that finding was shared with the regulator, but was not “entirely in the public domain”.
INDIA RULE
HYMN
The General Regulator of Drugs of India, VG Somani, who heads the Central Drug Standards Control Group, has approved a full two-dose regimen.
Announcing the permit on Jan. 3, Somani did not clarify the times between shots. Sources told Reuters that the doses would be given four weeks apart.
EFFICIENCY
Somani said the overall effectiveness of the AstraZeneca vaccine is 70.42%, based on overseas studies of 23,745 participants aged 18 or older. Phase II / III clinical trials on 1,600 participants in India showed data “compared to those from the overseas clinical studies”.
Composed by Josephine Mason and Krishna Das; Edited by Jan Harvey