U.S. Vaccines Usher in an Important Moment : Johnson & Johnson Suspends Phase III Trials, Pfizer announces to include Children

According to Russian media reports, Pfizer has become the first Western pharmaceutical company to start child trials of the new coronavirus vaccine, and has received approval from the U.S. Food and Drug Administration (FDA). Expand its Phase III trial to approximately 48,400 participants, including 12-year-old children.
 

Pfizer Pharmaceuticals said in its latest news released on October 12 that it has received federal government approval to conduct pediatric trials. The company explained that testing on young volunteers will help researchers better understand the vaccine’s effectiveness. Potential safety and effectiveness in people with a wider age and background.
 

According to a Pfizer spokesperson, at present, the company's new coronavirus vaccine trial has entered the final stage. Based on the original 44,000 volunteers, 4400 new volunteers will be added. While expanding the scope of the trial, Pfizer and some other pharmaceutical companies are racing to conduct Phase III trials and seek emergency FDA approval for their vaccination. Pfizer is currently in the leading position and is the first company to start trials on children. The company said it expects to obtain data on vaccine effectiveness by the end of October.
 

According to the report, vaccine trials are usually carried out gradually, starting with healthy adult volunteers, and as data accumulates, they enter age groups with varying degrees of vulnerability. Although pediatric trials are a necessary stage before the promotion and application of the vaccine, researchers studying the new coronavirus vaccine are paying more attention to the elderly who are particularly sensitive to the disease.
 

Moderna, another leading drugmaker developing a new coronavirus vaccine, said that the company plans to start trials in children by the end of 2020, while Johnson & Johnson previously stated that it will conduct research for children "later this year" after the safety of adult trials is determined. .
 

However, Johnson & Johnson said on the 12th that because one of the volunteers involved in the study had 'unexplained symptoms', it had suspended ongoing research on the new coronavirus vaccine. This is the second major setback in the late-stage trials of the new coronavirus vaccine development in the United States. Earlier on September 8, AstraZeneca Pharmaceuticals suspended the third phase of the global clinical trial due to 'severe side effects' in a subject. At present, the test has been restarted in the UK, but some of the tests in the United States are still suspended, waiting for more data to prove.
 

According to new federal guidelines issued last week, vaccine manufacturers are encouraged to monitor trial participants for at least two months after the last vaccination to detect any possible adverse reactions and whether they maintain a strong immune response . Although Pfizer is currently the leader among all vaccine candidates, the new regulations mean that the FDA’s emergency approval will not be until sometime in December at the earliest, which may frustrate President Trump’s plan to prepare for vaccination before election day .