Karmen Trzupek, MS, CGC, Director, Rare Disease Genetics and Clinical Trial Services at InformedDNA, talked to Med Ad News about an array of topics including the impact COVID-19 has had on clinical trials throughout the industry.
The United States on June 10 raised the pressure on other Group of Seven (G7) leaders to share their vaccine hoards to bring an end to the pandemic by pledging to donate 500 million doses of the Pfizer coronavirus vaccine to the world’s poorest countries.
Ocugen had to change the Pennsylvania-based eye disease company’s application for the Covid-19 vaccine Covaxin from an Emergency Use Authorization to a full Biologics License Application (BLA) approval.
Preliminary findings from two vaccine safety monitoring systems suggest a higher-than-expected number of cases of heart inflammation after the second dose of mRNA Covid-19 vaccines in young men, the U.S. Centers for Disease Control and Prevention (CDC) said on June 10.
Johnson & Johnson said on June 10 the U.S. Food and Drug Administration extended the shelf life of the company’s single-shot Covid-19 vaccine from three months to four-and-a-half months, as millions of unused doses nationwide near expiration.
Moderna Inc. filed for U.S. authorization to use the company’s Covid-19 vaccine in adolescents aged 12 through 17, potentially offering healthcare providers and pediatricians an easier-to-store shot ahead of the return-to-school season in the fall.
The Biden administration plans to donate 500 million Pfizer coronavirus vaccine doses to nearly 100 countries over the next two years, three sources familiar with the matter told Reuters on June 9.
Pfizer Inc. will start a large study to test the company’s Covid-19 vaccine in children below 12 years and selected a dosing regime for the clinical trial.
Safety concerns about Johnson & Johnson’s Covid-19 vaccine along with overall flagging demand for vaccinations have slowed its U.S. rollout to a crawl, leaving close to half of the 21 million doses produced for the United States sitting unused.
The United States had administered 301,638,578 doses of Covid-19 vaccines in the country and distributed 371,520,735 doses as of the morning of June 6, the U.S. Centers for Disease Control and Prevention said.