EMA recommends Johnson & Johnson Covid vaccine for approval; Developed in Leiden

The European Medicines Agency gave a positive recommendation of the Johnson & Johnson vaccine against Covid-19 for use by adults aged 18 and up in the European Union on Thursday. If the European Council gives the go-ahead, the vaccine which was developed by the company's Janssen subsidiary in Leiden will be the fourth approved for use in the Netherlands.

Unlike the other three approved vaccines - AstraZeneca, Pfizer/BioNTech, and Moderna - which require two doses of the vaccine each, the Janssen vaccine requires only one dose to inoculate a person against Covid-19. It also can be kept for extended periods of time at cool temperatures in a more standard refrigerator, making logistics less complicated and increasing the possibility of more physicians maintaining a supply at their offices.

"After a thorough evaluation, EMA’s human medicines committee (CHMP) concluded by consensus that the data on the vaccine were robust and met the criteria for efficacy, safety and quality," the EMA wrote in a statement. Side effects were reportedly mild, and mainly involved pain at the injection sight, headaches, muscle pain, nausea, and tiredness. Side effects usually cleared up within a few days.

So far, test results showed that the Janssen vaccine is 67 percent effective on average in preventing symptomatic cases of Covid-19. Both the Pfizer and Moderna vaccines rated above 90 percent, and the AstraZeneca candidate had a 73 percent efficacy. The Janssen vaccine was trialed later than the others, which could have had an impact on results as it may have been tested at a time and in locations like South Africa when mutations of the SARS-CoV-2 coronavirus quickly emerged.

According to Professor Ben van der Zeist, the different results may also have to do with the fact that the Janssen vaccine only requires one dose, not two. "If Janssen were to inject twice, the effectiveness might also be higher," Van der Zeist said to RTL Nieuws. A study is currently underway into how effective the vaccine is with two doses.

"It may well be that they later switch to two injections instead of one."

The European Union ordered 200 million doses of the Johnson & Johnson vaccine for the year, 55 million of which are expected in the second quarters. The Netherlands is entitled to 3 million doses in the second quarter delivery. Though earlier this week, an EU official told Reuters that the pharmaceutical was having production problems and the delivery may be late.