On Wednesday morning, the United Kingdom authorized AstraZenecain (NASDAQ: AZN) candidate vaccine against coronavirus for emergency supply. The first doses of the COVID-19 AstraZeneca Vaccine (formerly known as AZD1222) will be launched today with the intention of starting vaccination at the beginning of the new year.
The UK Medicines and Health Products Regulatory Agency (MHRA) recommends two full doses given four to 12 weeks apart. This is the dosage regimen that has appeared to be 62% effective in clinical trials in the UK and Brazil.
Source of images: Getty Images.
You must remember an unintentionally administered half-dose / full-dose regimen that seemed more than 90% effective in a smaller group of patients. Unfortunately, the data available for MHRA were not sufficient to persuade the agency to deviate from the two full doses received by the vast majority of clinical trial participants.
The European Medicines Agency (EMA) and the Food and Drug Administration are not on the same page as the MHRA. As a result, deadlines for similar authorizations for AstraZeneca are still confusing.
On Tuesday, EMA executive director Noel Wathion told reporters that AstraZeneca had not even filed the request yet. Although AstraZeneca sent some data, it was not enough to justify a conditional marketing license.
In the USA, the path to the front of the COVID-19 AstraZeneca vaccine will be uneven. The company’s CEO suggested that there will be more convincing clinical trial data, but the results we’ve seen so far don’t meet the FDA’s predetermined limit of effectiveness. In addition, the FDA has clearly stated that it does not wish to authorize a candidate without some essential data from an American study.