Pfizer Trial Using Lower-Dose Vaccine In 5- To 11-Year-Olds

ABC News: Pfizer Advances Clinical Trials For 5- To 11-Year-Olds At Lower Doses 
Pfizer is advancing Phase 2/3 clinical trials for young kids at lower doses than vaccines for adults, the pharmaceutical company announced Tuesday. Based on safety, efficacy and tolerability data from Pfizer's Phase 1 trial, the company will use 10 micrograms of each vaccine dose for kids between the ages of 5 and 11 in Phase 2/3 trials, and 3 micrograms of each dose for those 5 and younger. People ages 12 and older received 30 micrograms in each dose. (Schumaker, 6/8)

USA Today: Pfizer COVID Vaccine: Next Phase Of Trials In Young Children To Begin
Pfizer released details Tuesday about the progress of its COVID-19 vaccination trials in children, showing that they have completed early testing and are moving forward with lower-dose trials in younger kids. Children are less likely than adults to have a serious case of COVID-19, so drug companies are trying to minimize vaccine side effects while maximizing benefits. (Weintraub, 6/8)

Fox News: Pfizer Lowers COVID-19 Vaccine Doses For Younger Kids In Clinical Trial
Pfizer said it has selected lower dosages of its COVID-19 vaccine for Phase 2/3 portions of its clinical trial involving kids younger than 11 than the volume given to shot recipients ages 12 and older. For children ages 5-11 the vaccine will be given at a 10 microgram (ug) dose level, while those younger than 5 down to 6 months will receive a 3 ug dose level. The shots will continue to be given in a two-dose regimen. Currently, the FDA has granted emergency use authorization to Pfizer for its COVID-19 two-dose vaccine in people ages 12 and older. Everyone 12 and over receives two doses of 30 ug each given three weeks apart. (Hein, 6/8)

In other vaccine-development news —

CIDRAP: Single Dose Of Pfizer COVID Vaccine 51% Protective, Real-World Data Show
A single, 30-microgram dose of the Pfizer/BioNTech COVID-19 vaccine was 51% effective for any SARS-CoV-2 infection and 54% for symptomatic infections, according to a study yesterday in JAMA Network Open. The research cohort consisted of 503,875 Israelis 16 years and older who received a single dose from Dec 19, 2020, to Jan 15, 2021. A little more than half (52.4%) were women, the mean age was 59.7 years, and 69.8% had follow-up data for days 13 to 24 post-vaccination in addition to days 1 to 12. (6/8)

Fox News: Maine Says 8 Vaccinated Residents Died 'With COVID-19'
The Maine Centers for Disease Control and Prevention (CDC) has reported that eight residents who were fully vaccinated against coronavirus have died with COVID-19, including some who were inoculated while receiving end-of-life care. A coronavirus infection acquired 14 days post-final vaccination dose is considered a "breakthrough case." As of June 4, the state had reported 387 such cases. Breakthrough cases are expected, the CDC has previously said, and there may be a small percentage of fully vaccinated people who still get sick, are hospitalized or die from the virus. (Hein, 6/8)

The Boston Globe: Why Does The Johnson & Johnson Vaccine Work Against Variants? A New Study Suggests An Answer
New research suggests that Johnson & Johnson’s single-dose COVID-19 vaccine provides protection against worrisome virus variants — but perhaps not for the reasons researchers originally thought. The findings, published Wednesday in the peer-reviewed journal Nature, come from a 25-person study at Beth Israel Deaconess Medical Center in Boston, which looked at immune responses to variants first discovered in Brazil, South Africa, Southern California, and the United Kingdom. Twenty people in the study received the Johnson & Johnson vaccine, five received a placebo, and their blood samples were analyzed 57 and 71 days days after their shot. (Gardizy, 6/9)