Volunteers undergoing clinical trial of Coronavirus (COVID-19) vaccine in Spain have quit after reports of side-affects were reported last week in a volunteer undergoing AstraZeneca’s vaccine trial in United Kingdom (U.K.).
The vaccine which is being tested was developed by United States (U.S.) Corporation Johnson & Johnson. Phase-I trials were held in the U.S. and Belgium. The Phase-II trials are being held in Spain, Germany and Belgium. The trials in Spain are being carried out at 3 hospitals which include Marques de Valdecilla Hospital in Santande, La Paz University Hospital in Madrid and La Princesa University Hospital in Madrid.
The volunteers being tested at La Paz University Hospital in Madrid have quit the trial. The Lead Investigator of La Paz Hospital in Madrid – Alberto Borobia has confirmed there are enough volunteers in reserve to ensure the trial goes on uninterrupted.
Speaking to media – Borobia said, “Many have called to ask us some more detail about the risk of the vaccine, whether what happened with that vaccine had anything to do with the one we are studying, these types of questions.”
Johnson & Johnson’s Belgian Janssen unit began Phase-II trials of its COVID-19 vaccine on 190 people in Spain on Monday, i.e., September 14, 2020. These tests will conclude on September 22, 2020.
The Phase-II trials will study which dose and schedule of a vaccine generates the most antibodies. Post this, Phase-III trials will check the vaccine’s efficacy. Borobia also informed that Phase-II trials were scheduled to run for 14 to 16 months. But if some doses and schedules generate considerable amounts of antibodies, an intermediate Phase-III analysis could be conducted before the end of Phase-II.
Notably, the profile of volunteers for Phase-III trials will be completely different from those of Phase-II, which included people aged between 18 to 55 years and those above 65 years and having good health. In the third phase, J&J will study all types of people. People having different ailment such as hypertension will be included. The volunteers will be completely heterogeneous.
J&J will conduct the Phase-III trials on 60,000 volunteers. Of this, 20,000 volunteers will be from Latin America. The remaining will come from different geographies.
J&J is also one of the COVID-19 vaccine developers who took a pledge on September 8, 2020, to uphold scientific and ethical standards in the search for a vaccine. Other developers who took the pledge are Astra Zeneca, BioNTech, GlaxoSmithKline, Pfizer, Merk, Moderna, Sanofi and Novavax.
Separately, the first vaccines for COVID-19 are due to be available in early 2021. Pfizer and BioNTech SE proposed have proposed to the U.S. Food and Drug Administration (USFDA) to expand their Phase III vaccine trial to 44,000 participants from 33,000 to enrol.
Globally, there are 2,94,77183 cases of COVID-19 with 9,33,490 casualties. The U.S. is the worst affected country reporting 66,12,789 cases and 1,95,501 casualties. India is the second most hit country with 50,20,359 cases and 82,066 casualties. Brazil is the third most affected country having 43,82,263 cases and 1,33,119 casualties.
