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Johnson & Johnson’s COVID-19 vaccine authorised in US

J&J expects to produce at least a billion doses of its vaccine in 2021

Johnson & Johnson’s COVID-19 vaccine was granted emergency authorisation in the US. Results from a trial of about 44,000 participants show the J&J vaccine was 66 per cent effective in preventing moderate-to-severe COVID-19 globally. A review of available data by an independent safety monitoring board indicated that a single-dose of the COVID-19 vaccine was generally well-tolerated.


In South Africa, where 95 per cent of the cases in the trial were due to infection with the highly contagious B.1.351 coronavirus variant, the vaccine was 64 per cent effective in preventing moderate-to-severe COVID-19 28 days after inoculation. About 6,000 people in South Africa took part in the trial.

The level of protection from the vaccine against moderate-to-severe COVID-19 infection was 72 per cent in the US after 28 days.

The shot was 66 per cent effective at stopping moderate-to-severe cases in Brazil after 14 days and 68 per cent after 28 days. It was 66 per cent effective in Latin America overall, which involved nearly 18,000 people in Argentina, Brazil, Chile, Colombia, Mexico and Peru.

About 34 per cent of trial participants were over age 60. 17.2 per cent of participants in the trial were Black, 8.3 per cent were American Indian or Alaskan Native, 2.5 per cent were Asian and 45 per cent were Hispanic or Latino.

The FDA said the most common reactions were injection site pain at 48.6 per cent, headache at 39 per cent, fatigue at 38.2 per cent and aches and pains at 33.2 per cent. Other side effects included fever in 9 per cent of participants and high fever in 0.2 per cent of those who received the vaccine.

The Pfizer/BioNTech and Moderna vaccines use new messenger RNA technology to create an immune response and both require two shots. The one-shot J&J vaccine involves a more conventional approach, using a common cold virus to introduce coronavirus proteins into cells to trigger an immune response.

J&J’s vaccine remains stable for at least three months at normal refrigerator temperatures, while the Moderna vaccine must be shipped frozen and the Pfizer/BioNTech option must be shipped and stored at even colder sub-Arctic temperatures. These factors make it easier to vaccinate larger numbers of people, even in areas with poor transportation and storage infrastructure.

Pfizer/BioNTech and Moderna vaccines were about 94 per cent-95 per cent effective in trials conducted in the US where variants were not circulating.

Both mRNA vaccines showed higher efficacy rates in their trials than J&J’s vaccine, but experts cautioned against drawing too much of a distinction between the vaccines because the trials had different endpoints and J&J’s was conducted while highly transmissible new variants of the virus were circulating.

Novavax, which is testing its vaccine in South Africa, said it was 60 per cent effective at preventing mild, moderate and severe COVID-19 in patients who did not have HIV. It said about 90 per cent of cases in the study involved the new South African variant. The mid-stage South Africa trial included 4,400 patients.

The vaccine developed by AstraZeneca with Oxford University provided only minimal protection against mild-to-moderate COVID-19 from the South African variant in a relatively small trial. There was no data yet on its effectiveness in preventing severe disease in people who were infected by the variant because the study involved mostly young adults not considered to be at high risk for serious illness.

J&J expects to produce at least a billion doses of its vaccine in 2021 and has signed supply deals for most of that.

The US agreed to pay over $1 billion for 100 million doses and may purchase an additional 200 million doses.

Other deals include 22 million doses for Mexico, nine million for Colombia, 30 million in the UK, four million to South Korea and 400 million for the European Union. It plans to supply 500 million to poorer countries, working with the COVAX alliance.

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