While most of the country has been waiting to become eligible for the covid-19 vaccine, children under 16 were one of the few groups that were left out of initial studies all together. Now, parents and adolescents aged 12 to 15 have reason to celebrate, as data from the Pfizer/BioNTech vaccine Phase 3 clinical trials have been released via press release. The data demonstrated that the vaccine has 100 percent efficacy in preventing symptomatic infection in this age group. Of note, the press release did not specify whether the 100 percent efficacy figure reflected symptomatic cases or all infections (including asymptomatic infections), though at least one journalist suggested that it was the latter.
Conducted in the United States, the study enrolled over 2,000 adolescents, who were randomized to receive the mRNA vaccine or placebo. Researchers assessed the rate of symptomatic infection, as well as immune response, as measured by antibody levels. (Again, the rate of asymptomatic infection was not provided in the press release, though when the trial data are eventually released in full, that information may be included). The investigators found that not a single participant who received the vaccine developed symptomatic covid-19, compared to 1.6 percent (or 18 individuals) in the placebo group. Furthermore, the vaccinated subjects developed a strong antibody response. Also promising, the shot was well-tolerated, and side effects were similar to those experienced by 16-to-25 year old participants in prior studies.
Although the full results have yet to be published, these results are nevertheless exciting. On the tail of these data, we expect a forthcoming Emergency Use Authorization application for this age group to the US Food and Drug Administration. Next on the horizon, Pfizer/BioNTech has announced the start of Phase 1, 2 and 3 clinical trials to assess the safety, tolerability, and immune responses to their vaccine among children between 6 and 11.
BREAKING NEWS: The Department of Health and Human Services and the Centers for Disease Control and Prevention launch the Covid-19 Community Corps
As America and the nations around the globe navigate the hurdles of waxing and waning infection numbers, the race to herd immunity through mass vaccination campaigns has intensified. Now, health officials in the United States are looking for new and creative ways to get shots into arms. A new venture, announced by the White House and being launched today, is called the "COVID-19 Community Corps." The project is an initiative spearheaded jointly between the US Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC).
The concept of this program is to enlist the help of trusted voices in both local and national communities to help disseminate science-based information directly to the public in a more approachable manner. Most importantly, the Biden administration hopes this will be a successful mechanism to encourage communities across the country to get vaccinated. The administration will be providing its community partners with weekly scientific updates, social media suggestions, infographics, and tools that will help people find ways to get vaccinated. Doctors, nurses, various healthcare workers, and other entities (including Brief19) are now being approached to become founding members of the Community Corps, in order to develop a strong group of trusted voices with the goal of building vaccine confidence and sharing up-to-date information with the public.
While this program is in its infancy, we hope that the program will cross political party lines and bridge information chasms to successfully share the scientific progress being made in the fight against covid-19 and help people all around the country get protection against SARS-CoV-2.