By Andrew Atkinson
Two new COVID-19 vaccines made in Spain are being trialled, using a different technology, with only a single dose required to vaccinate a patient.
The vaccines will provide Spain with up to 100 million extra doses in the battle against the virus.
During the next few months three new Covid-19 vaccines are set to be approved by the European Union (EU).
A new vaccine produced by the Belgian company Janssen, which is a subsidiary of the US multinational Johnson & Johnson, is set to be approved by the EU on March 8, pending everything goes well, said Spanish Health Minister Carolina Darias.
The vaccine candidate is in the last stage of its clinical trial and if approved by the EU the vaccine from Oxford-AstraZeneca, Moderna and Pfizer-BioNTech will be approved by the European Medicines Agency (EMA).
In the USA, the Food and Drug Administration (FDA) will review the drug for emergency use on February 26.
The vaccine from Janssen, known as Ad26.COV2-S, has many advantages, principally that it only requires one dose. The 400 million doses committed to the European Union – 200 million with the option of an additional 200 million – would allow many people to be vaccinated.
Under the EU deal, Spain would receive more than 40 million doses of the vaccine which can last three months at a conventional cooler temperature, without needing to be frozen, and two years below 0ºC.
Similar to the AstraZeneca vaccine, which also does not require ultra-cold temperatures. It is being trialed by approximately 100,000 volunteers in several countries, including Spain which includes volunteers from the Phase 3 ENSEMBLE trial, which is testing the vaccine as a one-dose treatment, and another study of the drug as a two-dose inoculation.
A third of almost 50,000 participants in the ENSEMBLE investigation are over the age of 65, meaning the vaccine candidate will not face the same problems as the AstraZeneca vaccine, which has been restricted to people between the age of 18 and 55 in Spain, given that there is not yet sufficient evidence of its efficiency for the older age group.
The most recent results from the one-dose clinical trial show that the Janssen vaccine is 66% effective at preventing moderate to severe cases, and 85% effective at preventing critical Covid-19.
Dr Alberto Borobia is coordinating the Janssen clinical trial at La Paz hospital in Madrid.
The ENSEMBLE research study is designed to measure how well the vaccine protects people against moderate to serious cases of Covid-19.
La Paz is one of eight Spanish hospitals participating in the ENSEMBLE 2 trial, which is testing the Janssen vaccine as a two-dose treatment.
Recruitment of 30,000 volunteers will be monitored weekly, based on their symptoms.
The Ad26.COV2-S vaccine (most of the doses) will be made by the Catalan pharmaceutical company Reig Jofre.
The laboratory will receive the antigen and be tasked with producing and bottling it, capable of making 250 million doses annually.
Spain will also produce the vaccine from US company Novavax, awaiting approval by the EU.
A EU official told Reuters: “Talks with Novavax have intensified and we aim to agree the contract this week or next.” Novavax could deliver 100 million doses to the EU, with the option of 100 million more. The EMA is reviewing the results of the Novavax vaccine trial as they are released with a view to potentially authorizing the drug in April.
The Novavax inoculation uses a lab-made version of the protein that carries a new adjuvant, called Matrix-M.
“The antigen element that generates an immune response in the human body is made in insect cells. To do this, the virus is transformed into one that is only able to infect insects,” said Andrés Fernández, MD of Zendal group, based in Spain’s north-west Galicia region.
German biotech company CureVac will deliver at least 405 million doses of the vaccine, of which 10% will go to Spain. CureVac is also undergoing a clinical trial in Spain.
The study is at the Biocruces and Donostia hospitals in Spain’s Basque Country and the Clínico San Carlos hospital in Madrid.
30,000 Spanish volunteers are taking part. Antonio Portolés, the lead researcher at Clínico San Carlos hospital said: “The study was looking to test the immunogenicity of the vaccine against Covid to see whether it is possible to completely neutralize the virus and for those vaccinated not to spread the disease, once they are immunized.”