Sunday, 09 May, 2021


Health Canada confident in AstraZeneca vaccine despite data dispute

AstraZeneca manufacturing employee AstraZeneca vaccine is 79% effective against symptomatic COVID-19, company says
Bennie Garza | 24 March, 2021, 10:54

The company said its COVID-19 vaccine had a 79 per cent efficacy rate for preventing symptomatic COVID-19 and was 100 per cent effective in stopping severe disease and hospitalization.

"As is often the case", the spokeswoman said, monitoring boards "can request new or clarifying analyses of data from the trial".

The WHO has been raising concerns on equitable distribution of vaccines across the world. It promised to issue a primary analysis and "most up-to-date efficacy data" within 48 hours.

This is far from the first controversy faced by AstraZeneca over its vaccine, which is already authorised for use in Europe and elsewhere.

The product has not yet been authorized for use in the U.S.

"It was not necessary-if you look at it, the data really are quite good, but when they put it into the press release it wasn't completely accurate", he added.

Health Canada based its approval of AstraZeneca's vaccine in late February on earlier clinical trial data.

The vaccine has had a rocky rollout, especially in Europe, where it's now at the center of a supply showdown between the European Union and the U.K. Concerns about blood clots just days ago prompted around a dozen countries to suspend immunizations, though most have since resumed using the vaccine. That scepticism carried over to last week, when senior officials at a number of federal health agencies grew suspicious about why AstraZeneca had not announced data from its USA study.

In total, Serum Institute will deliver 240 million doses to various low- and middle-income countries (LMICs), including Ghana, Cote d'Ivoire, and India, under Covax by June at an agreed price of $3 per dose which will be borne by the facility's dedicated fund.

Many countries are relying heavily on the shot to end the pandemic, and several state leaders have taken it publicly to boost confidence. In Belgrade, Serbia, a sprawling exhibition centre set up for people to get the AstraZeneca vaccine was mostly deserted on Monday.

"At this point in time, we believe the benefits of the AstraZeneca vaccine continue to outweigh the risks", Sharma said.

Dr. Larry Corey, co-leader of the U.S. Coronavirus Vaccine Prevention Network, which helped design AstraZeneca's U.S. trial, said the monitoring panel's rebuke was something he had not seen before.

More context: The DSMB had expressed concern over AstraZeneca's announcements on its latest findings, according to a statement posted early Tuesday by the National Institute of Allergy and Infectious Diseases.

Last summer, at least some top FDA officials learned only from news reports that AstraZeneca had paused its Phase 2/3 vaccine trial in Britain after a participant developed neurological symptoms. Investigators ultimately concluded that the illnesses could not be linked to the vaccine. In the target group for the first round of vaccinations, 87.8 percent of patients and staff members in convalescent hospitals, 89.5 percent of patients and staff members in nursing homes and 82.4 percent of medical staff members at hospitals received their first shots of AstraZeneca or Pfizer vaccines as of Monday, the KDCA said. Still, the delay was a key reason that AstraZeneca fell so far behind the three other manufacturers whose vaccines have been granted emergency authorisation in the United States.

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