By Francesco Guarascio
BRUSSELS, Aug 11 (Reuters) – Johnson & Johnson could produce 1 billion doses of its potential COVID-19 vaccine next year if proven successful and would consider injecting healthy volunteers with the new coronavirus if there are not enough patients for definitive studies, a business executive said.
J&J began early-stage human safety testing in July for its potential COVID-19 vaccine after releasing details from a study in monkeys that showed that the best-performing candidate offered strong protection in a single dose.
It is developing the vaccine in collaboration with its Belgian subsidiary, Janssen.
Large-scale studies will begin in early October and J&J aims to have results on the effectiveness of the vaccine between the end of this year and mid-2021, Johan Van Hoof, head of faxing at Janssen, told Reuters in a telephone interview on Tuesday.
Earlier on Tuesday, President Vladimir Putin said Russia had become the first country to grant regulatory approval for a COVID-19 vaccine after less than two months of human testing, and before large-scale tests were conducted.
Van Hoof said production of the vaccine had already begun despite the financial risks involved, to ensure that it would be available as soon as possible if it proved effective against the new coronavirus.
Several million doses will be ready by the beginning of 2021, with a total capacity of 1 billion shoes by the end of the year, he said. He added that the company would likely favor a single-jab approach, although a final decision on whether a booster was needed had not yet been made.
ETHICAL AFFAIRS
Outcomes of large-scale, as phase III, trials will depend on the incidence of infections, Van Hoof said, with faster results expected with higher virus transmission.
Therefore, J&J is likely to conduct these trial cases in the United States and Latin America, the regions of the world currently with the highest number of cases.
If infections decrease significantly, J&J also considers so-called challenge tests, in which volunteers are infected with the virus so that a vaccine candidate can be tested on them.
“We are investigating that possibility,” Van Hoof said, noting that such subjects posed ethical issues that needed to be resolved before they could be conducted. For example, an effective therapy against the disease should be available to minimize risks to volunteers exposed to the virus.
In May, British drugmaker AstraZeneca, which is developing a leading coronavirus vaccine with the University of Oxford, said it was too early to deliberately expose subjects to the pathogen, but that it could become an option if ongoing testing hits the fence. .
Van Hoof said preparations to determine the virus for possible challenge tests were already underway and J&J was part of ongoing discussions with universities and other agencies involved in these projects.
“We find it a very interesting idea,” he said, adding that setting up facilities for such trials might take longer than faxing tests on people already infected in the community – as long as the transmission is relatively remained high.
(Report by Francesco Guarascio; edited by Emelia Sithole-Matarise)
