J&J and Pfizer line up in Covid-19 vaccine race      

Johnson and Johnson confirm they are planning a "robust" trial period for their Covid-19 vaccine 

Johnson and Johnson compete with Pfizer to get Covid-19 vaccine over the finish line 

As the race for a Covid-19 vaccine gets closer to the finish line, investors are parsing details of trial designs like never before as they handicap which is most likely to succeed.

Johnson & Johnson confirmed it plans to test its Covid-19 vaccine in as many as 60,000 people, twice the number of other big trials being conducted in the US. The company first posted the design for the trial on August 10, and it is set to begin in late September.

Meanwhile, Pfizer released favourable safety data from a Phase 1 trial of its vaccine. The New York-based company, which is developing its product with German partner BioNTech, hadn’t previously released safety data on the shot it will move into a final-stage trial.

“Investors are trying to decipher who’s going to be the winner and who might be left behind,” said Yaron Werber, a Cowen analyst. 

The Pfizer data support the company’s “slight lead” in the race, according to Werber. J&J researchers, meanwhile, “are buying themselves a lot of insurance” with an extra big trial aimed, he said, at making “sure they are coming out with positive data”.

There are more than 160 Covid-19 vaccines being developed worldwide, and about 30 have entered human trials, according to the World Health Organiaation. 

Even before scientists know whether the inoculations will work, many of the furthest-along companies are already starting to produce the products and cutting deals to supply shots to governments worldwide.

In the US., two messenger RNA vaccines have entered final-stage trials, including Pfizer’s vaccine and a competing shot from the biotech company Moderna. 

“We can confirm that planning and recruitment is underway” for J&J’s Phase 3 trial, company spokesman Jake Sargent said. The trial plan “is intended to be as robust as possible,” he said, and will be conducted in places with high rates of Covid-19, based on epidemiology and modeling data.

On the surface, the J&J trial will be about twice as big as the final-stage vaccine trial underway at Pfizer. In an interview, Philip Dormitzer, Pfizer’s vice president of viral vaccine research, said the US's high infection rates means the company expects to hit the needed number of Covid-19 cases with 30,000 people or less.

If the incidence rate suddenly drops, the trial size could be increased, he said. The trial is enrolling rapidly and had more than 9,000 volunteers as of August 19. 

“Things are going very quickly,” Mr Dormitzer said. “We remain on target” to have results ready to submit to regulators in October.

The US Food and Drug Administration is tentatively planning to hold an advisory panel meeting on October 22 to discuss Covid-19 vaccines, according to Anand Shah, the agency’s deputy commissioner for medical and scientific affairs. 

Pfizer’s Dormitzer said he couldn’t say whether Pfizer would have results in time to present at this meeting.

Pfizer and BioNTech also posted Phase 1 data from its vaccine candidate on medRxiv.org, a preprint site for research results that haven’t yet been published. Bloomberg