AstraZeneia's COVID-19 vaccine is expected to receive provisional approval in the UK for a planned new half-dose trial

The pharmaceutical giant said it would launch a new dose of the vaccine to help dispel doubts about the authenticity of data on the 90 percent effectiveness of AstraZeneta's COVID-19 vaccine trials.
like Pfizer and Moderna, AstraZeneta announced earlier this week that the positive results of its COVID-19 vaccine trial were as effective as 90 percent and that patients did not experience any serious side effects after vaccination.
However, with the details of the trial revealed, AstraZeneone's vaccine effectiveness was greatly challenged, and the test data proved to be quite watery, with 90 per cent of the trial conclusions due to the Ulong event in the trial.
When the company injected 2,700 subjects with a two-dose vaccine, due to operational errors, the patients were given only half the dose in the first round and only the full dose in the second round, so up to 90 percent of the effectiveness came from the "half-dose plus one dose" method, while the other 8,895 subjects received only 62 percent effectiveness of the complete two-dose vaccine.
ASTRAZEN COVID-19 vaccine candidate AZD1222 has received $1 billion in support from the U.S. federal government's Opera Warp Speed program.
July, AZD1222 released phase I positive data, and patients vaccinated with the vaccine produced not only meso-antibodies, but also immune T cells against the COVID-19 virus.
analysis of current trial results shows that the average effectiveness of AstraZeneta's COVID-19 vaccine remains at only about 70%, well below the competitor's level of about 90%.
AstraZeneta has said it will launch a new round of global clinical trials of "low-dose injections" that achieve higher effectiveness in trials to test the effectiveness of the "half-dose plus one-dose" treatment.
, however, the British government seems to believe that the current test results have met the conditions for approval.
, the UK government has asked national regulators to consider provisional approval of AstraZeneta's COVID-19 vaccine for temporary use as soon as they receive safety, quality and efficacy data.
, officials from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) have begun assessing data on the viral vector vaccine AZD1222 under a rolling review programme.
pressure to reduce COVID-19 cases without damaging the economy, the British government has formally asked the MHRA to assess the suitability of AZD1222 for temporary supply.
once approved, the UK could begin vaccinating high-risk groups, with 4m doses expected by the end of the year, with plans to give priority to the elderly and staff in care homes.
the US market has not been as smooth as in the UK.
Pascal Soriot, chief executive of AstraZeneca, said in an interview with Bloomberg that the additional study could be conducted globally, but noted that the study could move forward more quickly because we already know that this low-dose therapy is highly effective, so we only need to recruit fewer patients.
"the company's vaccine licensing in the U.S. may be delayed due to differences in validity data from other competing products."
Soriot said, "The question is whether U.S. approval requires data from the U.S. trial or from an international trial, and it's not clear whether it's likely that the U.S.-based test data is needed to obtain regulatory applications at this time."
", the mRNA vaccine developed by Modelna, Pfizer and BioNTech all claims to be 95 percent effective.
, Pfizer and BioNTech are awaiting regulatory scrutiny of their data, which is expected to take place next week, with emergency use authorizations likely to be submitted shortly.
source: 1.AstraZeneca nears temporary OK for COVID-19 vaccine, plots extra trial 2.AstraZeneca Looks to Clear Confusion Over Vaccine Results with Additional Studies