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VACCINE

Spain approves late-stage trial of coronavirus vaccine

Spain has authorised the launch of late-stage trials of Johnson and Johnson's Covid-19 vaccine candidate, which will also be tested in eight other nations.

Published: 18 November 2020 18:11 CET
Spain approves late-stage trial of coronavirus vaccine
Photo: AFP

The phase 3 trial will be carried out in nine hospitals across Spain involving volunteers both with and without underlying health conditions, the national medicines agency AEMPS said in a statement on Wednesday.

Trials of the two-dose vaccine will involve up to 30,000 volunteers in Belgium, Colombia, France, Germany, South Africa, Spain, the United Kingdom, the United States and the Philippines, said the agency.

The agency did not say how many people would take part in Spain, only that the hospitals involved would begin recruiting volunteers “as soon as possible”.   

Twenty percent of the volunteers will be under the age of 40, and 30 percent will be over 60. They will be given either a dose of the experimental vaccine dubbed Ad26.COV2.S or a placebo.

“These trials are essential to guarantee the quality, safety and effectiveness of vaccines,” the agency said, indicating the results would be made available after all the data is analysed at the end of the trials.

Johnson & Johnson carried out mid-stage phase 2 trials of the vaccine in September in Spain and other countries.

This will be the first phase 3 trial in Spain for a vaccine against Covid-19, according to the medicines agency, a unit of the health ministry.    

According to World Health Organization protocols, a candidate vaccine must complete three phases of clinical trials to be approved for industrial production.

Phase 3 trials are the largest. A vaccine is deemed ready to move into industrial production once this last phase provides clear evidence of its safety and efficacy.

Two other firms, Pfizer and Moderna, announced this week that their candidate vaccines had shown over 90-percent efficacy in their phase 3 trials.

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COVID-19

Public Health Agency recommends two Covid doses next year for elderly

Sweden's Public Health Agency is recommending that those above the age of 80 should receive two doses of a Covid-19 vaccine a year, once in the spring and once in the autumn, as it shifts towards a longer-term strategy for the virus.

Published: 23 December 2022 10:53 CET
Public Health Agency recommends two Covid doses next year for elderly

In a new recommendation, the agency said that those living in elderly care centres, and those above the age of 80 should from March 1st receive two vaccinations a year, with a six month gap between doses. 

“Elderly people develop a somewhat worse immune defence after vaccination and immunity wanes faster than among young and healthy people,” the agency said. “That means that elderly people have a greater need of booster doses than younger ones. The Swedish Public Health Agency considers, based on the current knowledge, that it will be important even going into the future to have booster doses for the elderly and people in risk groups.” 

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People between the ages of 65 and 79 years old and young people with risk factors, such as obesity, diabetes, poor kidney function or high blood pressure, are recommended to take one additional dose per year.

The new vaccination recommendation, which will start to apply from March 1st next year, is only for 2023, Johanna Rubin, the investigator in the agency’s vaccination programme unit, explained. 

She said too much was still unclear about how long protection from vaccination lasted to institute a permanent programme.

“This recommendation applies to 2023. There is not really an abundance of data on how long protection lasts after a booster dose, of course, but this is what we can say for now,” she told the TT newswire. 

It was likely, however, that elderly people would end up being given an annual dose to protect them from any new variants, as has long been the case with influenza.

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