Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval.
This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the EUA for Veklury to authorize the drug’s use for treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. Clinical trials assessing the safety and efficacy of Veklury in this pediatric patient population are ongoing.
Pneumonia Vaccine Demand Rockets
Demand for Merck’s Pneumovax 23, which is used to prevent pneumococcal lung infections, has hit record highs across the world, the company said. More than 40 companies and researchers are testing vaccines against the novel coronavirus, but none have been approved in the West. In the meantime, doctors are giving the pneumonia shot to more people than ever as a preventative measure. Pneumococcal prevention, the largest segment of the vaccine market by value, rang up about $7 billion in sales in 2019, contested by Pfizer PFE.N, Merck and GlaxoSmithKline GSK.L.
Pfizer’s Prevenar 13, known as Prevnar 13 in North America, is the global market leader, and brought in about $5.8 billion in sales in 2019. It works for both infants and the elderly but it covers fewer bacterial strands than the Merck product. GSK’s Synflorix is designed for children. Usage differs by country, but Pneumovax 23, which lasts about five years, is primarily given to the elderly. “During the rapidly evolving COVID-19 situation, there has been increased emphasis on adult vaccination, and we have seen an unprecedented surge in demand for Pneumovax 23 around the world,” a Merck spokesman told Reuters in an email.