Coronavirus: Vaccine verdict ‘by Christmas’, says top US adviser Anthony Fauci

US trials are expected to show later this year whether a Covid vaccine is effective and safe, Anthony Fauci says.

Anthony Fauci, director of the US National Institute for Allergy and Infectious Diseases, adjusts his face mask during a congressional subcommittee hearing on coronavirus, where he was a witness. Picture: Kevin Dietsch/pool/ AFP

Trials under way in the US are expected to show before the end of the year whether a Covid vaccine is effective and safe, the country’s leading infectious diseases expert has told The Times.

Anthony Fauci, a senior adviser to US President Donald Trump, said that high infection rates across the US were boosting the chances of conclusive safety and efficacy data being available for at least one jab before Christmas.

Three vaccines have been lined up for testing under the White House’s “Operation Warp Speed” plan to deliver 300 million doses by January. Having results by November or December was “a safe bet”, Dr Fauci said. “It is conceivable that we would get an answer before that.”

He added that he would oppose any attempt to rush through a vaccine for political purposes. It was alleged this week that the White House had considered skirting normal regulatory procedures, in order to make an announcement before the presidential election on November 3.

“I would not be satisfied until a vaccine was proven to be safe and effective, before it was actually approved for general use,” Dr Fauci, who leads the National Institute of Allergy and Infectious Diseases, said.

His meetings with Mr Trump – during which he was not afraid to contradict the President, to the delight of Trump critics – had become “sporadic”, he said.

They met almost every other day in the early stages of the pandemic, which has now claimed more than 170,000 American lives.

The director of the US National Institute of Allergy and Infectious Diseases, Anthony Fauci, flanked by President Donald Trump, speaks during the daily briefing on coronavirus last April. Picture: AFP

Trials funded by the US government for two vaccines, one from the American biotech company Moderna and the other from the US drugmaker Pfizer and BioNTech, a German company, have each enrolled more than 15,000 subjects in America. They are both aiming for 30,000.

The White House is also providing funding for a trial of a vaccine from Oxford University and Astrazeneca, the British drugmaker. It will also enrol 30,000 participants.

Astrazeneca said on Friday that the first doses should be administered to volunteers “in the coming days”.

Dr Fauci said: “The way the pace of the enrolment is going on and the level of the infections that are going on in the United States, it is likely that we’ll get an answer by the end of the year. I would say a safe bet is at least knowing that you have a safe and effective vaccine by November, December.” He did not say which vaccine he considered the frontrunner.

The British government has revealed plans to amend the law to ensure that EU regulations do not slow the deployment of a vaccine if positive trial data emerges before January 31, when the Brexit transition period ends.

The proposed changes would also allow thousands of health sector workers, including pharmacists, physiotherapists and midwives, to be trained to give the injections.

A senior government official said that there was a “small but plausible” chance that doses of a safe and effective jab will be ready before the end of the year.

The groundwork was being laid to get them “into British arms as fast as possible” without EU safety watchdogs slowing down the process. No shortcuts would be made on testing for safety and effectiveness, officials insisted. The Oxford vaccine is seen as the most advanced.

The government wants to spell out in legislation that the Medicines and Healthcare products Regulatory Agency is able to grant a vaccine an emergency temporary authorisation – “provided it meets the highest safety and quality standards”.

The change is necessary because, during the Brexit transition period, a new vaccine would normally have to receive a licence from the European Medicines Agency before being used. A government source said that the UK was determined not to be snarled in EU “red tape”.

The proposals also include amending the law to make it clear that companies such as Astrazeneca would have protections from civil liability if UK regulators gave the green light to an unlicensed vaccine.

A senior government official insisted that no shortcuts would be made on safety. Processes that usually happened sequentially were taking place in parallel, he said.

“If the MHRA normally asks for 10 ticks in 10 separate boxes before a vaccine is authorised, it will in these circumstances also ask for the same 10 ticks,” he said.

Jonathan Van-Tam, deputy chief medical officer for England, said: “If we develop effective vaccines, it’s important we make them available to patients as quickly as possible, but only once strict safety standards have been met.

“The proposals consulted on today suggest ways to improve access and ensure as many people are protected from Covid-19 and flu as possible without sacrificing the absolute need to ensure that any vaccine is safe and effective.”

A three-week consultation on the proposals started on Friday.

The Times