COVID-19 vaccine: AstraZeneca, J&J gets US approval to resume trials

By Rahul Vaimal, Associate Editor
  • Follow author on
COVID-19 Vaccine
Representational Image

UK-based pharmaceutical company AstraZeneca and Johnson & Johnson, the US-based multinational, are all set to restart clinical trials of their COVID-19 vaccine that were suspended by US authorities.

Following approval by regulators, AstraZeneca has already resumed the US trial of its experimental COVID-19 vaccine while Johnson & Johnson (J&J) is planning to restart its trial within 2-3 days, the firms said. This resumption will place studies back on track for two of the leading candidates for coronavirus vaccination.

Read More: We are at a critical juncture in the COVID-19 pandemic: WHO Chief

J&J said in a statement recently that it is planning to restart recruiting volunteers, after consultation with the US Food and Drug Administration (FDA), for its late-stage trial of its vaccine. An independent data security monitoring board had recommended that trial can proceed. After a patient became ill, the research was halted earlier this month, but the company said that the specific cause of the disease has not been found.

AstraZeneca said earlier that the FDA had cleared it to resume a trial that had been suspended in the US after a volunteer who took part in the trials in the UK had fallen ill. The company said that the agency had reviewed global research data and concluded that it was safe to proceed.

Allowing the experiments to move ahead removes a shadow that in recent weeks had been hanging over the attempt to find a vaccine. For more than a month, the AstraZeneca trial had been in uncertainty, while J&J’s trial had been suspended since October 12. Together with rivals Pfizer and Moderna, the firms are among the front-runners in the search for a vaccine to tackle COVID-19 which has infected 7.81 million globally.

J&J trials

J&J is testing its vaccine candidate in a 60,000-person trial, which is expected to give out data before the end of the year. The firm has indicated that it might approach US regulators for an emergency-use authorization, as early as the beginning of 2021.

After learning about the volunteer’s critical illness, the US-based healthcare giant halted the trial. During the break, in addition to its own thorough analysis, J&J had three independent outside medical consultants examine in depth to understand what happened, said Paul Stoffels, chief scientific officer of J&J.

“We have found no evidence it was linked to the vaccine,” Mr. Stoffels said. Pauses due to adverse events are quite common in big trials, he said.

He said that test sites could be up and running again in 2 days, resulting in only a small delay. The company continued with logistical work even during the pause to get more test sites supplied and ready.

Mr. Stoffels added that he was prohibited from revealing the nature of the serious adverse condition of the patient due to privacy agreements. The company also refused to say whether or not the volunteer who got sick received the vaccine.

AstraZeneca trials

Questions have swirled around the shot by AstraZeneca since a September announcement that a participant in a UK was infected with a severe neurological condition. Since then the drugmaker and Oxford University, with which it is developing the vaccine, have faced pressure to reveal more information about the episode. Although nations such as Brazil, South Africa and the United Kingdom have let trials of the vaccine resume, the US proceeded with its review.

Further, the news of a trial participant’s death in Brazil had raised more concerns while later reports suggested that the participant was not given the AstraZeneca vaccine. These incidents raised questions about one of the fastest-moving shots’ prospects and demonstrated the challenges facing researchers when developing a vaccine.

AstraZeneca said in a statement that in large-scale vaccine trials, it is not uncommon for certain patients to become unwell. Results are expected later this year from its late-stage trials, the company said.

“We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use,” Chief Executive Officer of AstraZeneca, Pascal Soriot said.

Global health experts have expressed concern that the vaccine trials are likely to be influenced by political pressure as the US election, which is scheduled to be held on November 3, gets closer.

Stay Updated: India’s 1st COVID-19 vaccine to begin Phase 3 trials; Assures 60% efficiency