Covishield ‘safe’

The Serum Institute of India (SII) said yesterday that vaccine candidate 'Covishield', which is being developed by Oxford University and AstraZeneca for the coronavirus disease (Covid-19), is "safe and immunogenic". The SII is testing the candidate in India.

The company also said that the incident with one of the volunteers during clinical trials was "no way induced by the vaccine".

"All regulatory, ethical processes and guidelines were followed by the company. The principal investigator DSMB (Data and Safety Monitoring Board) and ethics committee stated it was non-related issue to vaccine trial," news agency ANI reported, quoting a statement from the SII.

The Pune-based company also said that it has sent a legal notice to a man who claimed he had developed serious side-effects in the human trials. "The legal notice was sent to safeguard the reputation of the company which is being unfairly maligned," ANI quoted SII as saying.

The man had served a legal notice on SII, claiming to have suffered a virtual neurological breakdown and impairment of cognitive functions, seeking Rs 5 crore in compensation and a halt to the trial.

The SII has collaborated with Oxford University and AstraZeneca Plc in testing Covishield, the vaccine candidate they developed.

Along with SII, the man also named Indian Council of Medical Research, one of the sponsors, and Chennai-based Sri Ramachandra Institute of Higher Education and Research, which administered the vaccine to the man.

The man, according to the notice, suffered acute encephalopathy, a disease that affects the brain, following vaccination and all tests confirmed that the setback in his health was because of the vaccine candidate.

The Drugs Controller General of India (DCGI) had deployed an institutional ethics committee at the implementation site to investigate the adverse event.

In Europe, the European Commission is likely to give the final authorisation for the roll-out of Covid-19 vaccines days after the EU drug regulator approves them, a spokesman for the EU executive said.

The European Medicines Agency (EMA) said earlier yesterday it planned to decide whether to approve the vaccine being developed by Pfizer and BioNTech by December 29, and by January 12 on the shot being developed by Moderna.

"It's probably a matter of days. The goal is to do it rapidly," the spokesman told a news conference, adding the exact date depended on the EMA's possible authorisations.

The virus has so far killed at least 1,468,873 people since the outbreak emerged in China last December, according to a tally from official sources compiled by AFP yesterday.

More than 63,227,478 cases of coronavirus have been registered.

The US is the worst-affected country with 268,103 deaths, followed by Brazil with 173,120 deaths, India with 137,621 deaths and Mexico with 105,940 deaths.

California's governor said on Monday the state was at a "tipping point" in the pandemic that would soon overwhelm hospitals as political leaders nationwide turn to increasingly aggressive measures to hold back the latest surge.

Governor Gavin Newsom said he may clamp new "stay-at-home" orders on California's roughly 40 million residents in the face of infections and hospitalizations that are still rising weeks before emergency vaccines are predicted for release.

The governor told reporters discussions were underway among state health officials over the potential stay-at-home order. He expects to issue a decision in the next day or two.

Americans who have endured eight months of restrictions, lockdown and business closures in the face of the pandemic are pinning their hopes on vaccines developed by drug companies Pfizer Inc and Moderna that are awaiting US government approval for emergency use.

US Health Secretary Alex Azar said Pfizer's medication could be authorized and shipped within days of a December 10 meeting of outside advisers to the Food and Drug Administration, reports Reuters.

Meanwhile, Dr Scott Atlas has resigned as special adviser on the coronavirus to President Donald Trump, a White House official said on Monday, after a controversial four months during which he clashed repeatedly with other members of the coronavirus task force.

Hong Kong and Singapore yesterday indefinitely delayed a "travel bubble" in a new blow to their hard-hit tourism and aviation industries as the Chinese city battles a coronavirus surge.

The arrangement allowing people to travel between the financial hubs without quarantining had been due to launch on November 22, but was postponed for two weeks as Hong Kong saw a sudden spike in cases.