FDA approves first vaccine for coronavirus

The first vaccine for the Coronavirus type 1 (Coronavirus disease) cleared by the US Food and Drug Administration (FDA) has been conducted by Pfizer in collaboration with the Qatar National Health Authority (GNHA). The multi-dose, virus-specific product has been tested and validated in children and adolescents age 2 to 17. This is the first time a vaccine has been cleared by the FDA for a Coronavirus type 1. The vaccine is used for prevention of Coronavirus disease.

The experimental vaccine combines an adjuvant (used to heighten the effect of vaccines) and a polyisocyanurate (used to inhibit the immune system from fighting the vaccine) that are developed and are currently in clinical trials in infants and children. “These trials have been conducted in infants and children between 6 months and 2 years of age. This has allowed us to optimise the vaccine to reduce immune responses, which is important for children under 2 years of age,” said Muhammad Al-Nakhal, Director of INFRAZA for CMC Industries Qatar (cMC Industries). “More than 99% of infants and children who have received the vaccine are maintaining the vaccine in the total body and not rejecting it.”

The prevalence of Coronavirus type 1 vaccination programmes in Qatar began in 2012 with CMC Industries launching a program in the western region with several healthcare partners. The primary aim of the programme is to protect those under the age of 18 who are at risk of developing Coronavirus disease. Currently, there are approximately 7,500 under-18s in Qatar who are vaccinated with the product by healthcare professionals and public health staff through screening programs.

Coronavirus type 1 represents the second most dangerous infection to humans after SARS. SARS (Severe Acute Respiratory Syndrome) struck 31 countries in Asia, the Middle East and Europe in October 2002. There were 865 reported deaths in these 36 countries. Coronavirus disease can cause septicemia (blood poisoning) and severe vasculitis (internal bleeding). Coronavirus is a respiratory disease caused by a virus. Therefore, to protect the vaccination, disease incidence is estimated to be low in endemic countries. WHO has reported that the Coronavirus strain is found primarily in the Middle East and North Africa, where it is spread via the air from person to person or in household contaminated objects.

“During the course of the safe use of this vaccine, Coronavirus type 1 is expected to be a worldwide epidemic. One of the critical components of the regulatory assessment for this vaccine was that both the efficacy and safety data be sufficient to enable the product to be placed on the market and its efficacy and safety data to be used to advise healthcare providers on the appropriate age and dose to use,” said Dr. Opeyemi A. Alabi, MD, FACP, Assistant Commissioner for Medical Affairs, Jinnah Hospital, USA.

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