Spain approves Phase 3 clinical trials of Janssen's COVID-19 vaccine; trial at 9 hospitals

The Spanish Agency of Medicines and Medical Devices (AEMPS) on Wednesday has authorized phase-3 clinical trials of the COVID-19 vaccine developed by Janssen, the Spanish Health Ministry informed.  This will be the first COVID-19 vaccine that will be allowed to enter phase 3 trials in Spain.

Trials will be conducted in nine hospitals in Spain

The trials will be carried out in Belgium, France, Colombia Germany, the Philippines, the United Kingdom, the US, and South Africa to study the safety of the vaccine. Furthermore, the trials will be conducted in nine hospitals in Spain that will begin to recruit eligible volunteers, which include both people without any chronic diseases and people with concurrent illnesses. Twenty percent of the participants will be under 40 years old and 30 percent will be over 60 years old, the ministry informed.

The pharmaceutical company Janssen is a subsidiary of Johnson & Johnson and is developing a recombinant vaccine (Ad26.COV2-S) against coronavirus. The company had announced the start of phase 3 of the vaccine's trials in late September.

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Pfizer's COVID Vaccine Edges Past Moderna's Efficacy Rate

Days after reporting over 90 percent efficacy, Pfizer and BioNTech on Wednesday announced that its COVID-19 vaccine candidate - BNT162b2 - has met all of the primary efficacy endpoints. Concluding from the analysis, the biotech firm stated that its vaccine candidate has shown an efficacy rate of 95 percent in participants with and without prior COVID infection. However, the efficacy reduced by a percent in adults over the age of 65 years. The analysis by Pfizer and BioNTech is based on 170 participants. 

The companies have also announced that it has achieved the safety milestone required by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). Based on the safety and efficacy data collected, the firms intend to submit a request within days to the FDA for a EUA. The announcement comes just two days after Moderna reported that its vaccine candidate had shown nearly 95% efficacy rate. 

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Meanwhile, Moderna on Monday reported that its COVID-19 vaccine candidate has proven to be 94.5 percent effective. The biotechnology company has informed that it intends to submit the COVID-19 vaccine candidate for an Emergency Use Authorization (EUA) with the United States' Food & Drug Administration (FDA). The analysis released by Moderna which has reported 94.5 percent efficacy of the COVID-19 vaccine was based on results of more than 30,000 participants in the US.

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(With ANI inputs)