AstraZeneca (LON: AZN) Vaccine Model Yet to Clear the Doubts of US Regulator

Summary

  • The executive vice-president at AstraZeneca biopharmaceuticals R&D Sir Menelas Pangalos has expressed his doubts over early FDA approval for their vaccine
  • AstraZeneca has been facing criticism since it paused its Phase 3 trials in September after a woman representative developed a neurological disease -- transverse myelitis.
  • The researchers of AstraZeneca released the full data of their clinical trials in the Lancet medical journal

The United Kingdom was the first to roll out Pfizer/BioNTech’s vaccine on Monday (December 7), after it was found 95 per cent effective in final trials last month. But the homegrown vaccine candidate of AstraZeneca PLC (LON: AZN) and Oxford University is yet to receive Emergency Use Authorization (EUA) from UK regulator Medicines and Healthcare products Regulatory Agency (MHRA), US regulator Food and Drugs Administration (FDA), European Medicines Agency, and other authorities.

The executive vice-president at AstraZeneca’s biopharmaceuticals, Sir Menelas Pangalos has even expressed his doubts over getting FDA’s approval of the vaccine. AstraZeneca has been facing criticism after it paused its Phase 3 trials in September  after a woman representative developed a neurological disease named transverse myelitis.

Interesting Read: Pfizer-BioNTech Covid-19 vaccine ensures ‘overwhelmingly high efficacy’: US FDA

Criticism and lapses

The pharma major is also being questioned because of the efficacy results it released in November. The overall efficacy rate was 62 per cent, while when the experts tried another medication treatment, the efficacy was found to be around 90 per cent.   The results from the clinical trial showed that everyone who was vaccinated in the trial, nearly 70 per cent of them were not infected by the coronavirus.

To Know More, Do Read: COVID-19: AstraZeneca-Oxford’s Vaccine Shows 70 Per Cent Efficiency in Late-Stage Trials

On 8 December, the researchers of AstraZeneca released the full data of their clinical trials in the Lancet Medical Journal. It disclosed that the vaccine AZD1222 is capable of fighting 70 per cent of the Covid -19 cases. The study also revealed that only three of the 23,745 representatives experienced serious adverse effects over the period of time.

Adrian Hill, Director at Jenner Institute, who is a part of the research and development of AstraZeneca-Oxford vaccine, said that if FDA waits for the end result of the vaccine trial, the vaccine will not reach the United States before mid-2021. However, he said he hopes that the regulator would look at the data published and take a call.

On 6 October, the FDA had issued a new set of guidelines for Covid-19 vaccine developing companies, which highlighted that the companies should offer at least two months of follow up for safety data before applying for the EUA.

Meanwhile, in the UK, MHRA chief executive June Raine said that the authority would be looking at all the available data, including the data from earlier trials of AZD1222 along with the dosing regimen.

The AZD1222, which is much cheaper than its peers, has another advantage: it can be stored at a regular refrigerator temperature and doesn't need cold storage facilities.

Need for early vaccine

The roll-out of the vaccine for the masses is the only ray of hope for the world that has been struggling to overcome the pandemic, which has killed nearly 1.55 million people worldwide. The crisis has crushed economies, but the vaccines will surely be a turning point. Multiple vaccine candidates are in different stages of clinical trials, while others have released their final stage analysis and have sought authorization for urgent use.

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