WASHINGTON -- Federal officials stated Sunday that child-sized doses Pfizer's Covid-19 vaccines are safe and effective for children under 5. This is a crucial step towards the long-awaited decision about whether to start vaccinating American children as young as five.
The Food and Drug Administration published its analysis of Pfizer's shot before Wednesday's meeting, where outside experts will vote whether the shots are available for the nation’s 18 million infants, toddlers, and preschoolers. Only children under five are eligible for Covid-19 vaccine in the U.S.
The FDA published a similar analysis last week of Moderna's shots to children younger than 6.
If both the companies and regulators agree, then vaccinations can begin next week. Drugmakers will be ready to quickly ship the orders of the government if necessary. Federal officials have been pressed by parents for months to allow their children to be protected as more adults abandon public health precautions and remove masks.
Although only 3 percent of U.S. Covid cases involve children aged 6 months to four years, death and hospitalization rates for this age group are higher than the ones for older children, FDA analysis shows. Experts believe that protecting this group is crucial.
According to the FDA, children who were given Pfizer's shots in testing had high levels of virus-fighting antibody that could protect them from coronavirus. This is the minimum threshold to gain FDA approval. Additional testing revealed key differences that Pfizer was able to exploit with more powerful results.
Although the vaccine was administered as a three-shot series by Pfizer, it proved to be 80 percent effective in preventing symptoms of Covid-19. However, this calculation was based only on 10 cases among the study participants. As Pfizer continues its study, this number could change.
Moderna's two dose series was only 40 percent to 50% effective in preventing milder infections. However, the shots were administered at different times during the pandemic. Moderna is now testing a booster to help infants.
The FDA will request an independent panel made up of vaccine experts to discuss the data from both companies before it votes. Although the FDA is not required by law to follow the recommendations of the panel, the process is important in public vetting.
After Wednesday's all day meeting, the FDA will likely make an official decision. Next, the Centers for Disease Control and Prevention (which recommends how vaccines should be used) will convene an expert panel to discuss which babies need to be vaccinated.
It is not clear what the initial demand for shots will be. Recent research suggests that only one in five parents with young children would have their child vaccinated immediately. According to government statistics, vaccines are available for older U.S schoolchildren since November, but less than a third have received the recommended doses.
Each company offers different doses and numbers of shots for the youngest children. Moderna and Pfizer offer different dosage sizes for infants and toddlers, starting at 6 months to 4 years. Moderna is available from 5 years to 5 years.
Pfizer and BioNTech will offer two shots, one at a time, three weeks apart. The third shot will be offered at least two more months later. Each dose is approximately one-tenth of the adult dose. Pfizer currently has the only Covid-19 vaccine available for older U.S. kids.
Moderna seeks FDA approval for two shots. Each shot will be approximately 25% of the adult dose. They will be given roughly four weeks apart.
Moderna's vaccine is currently only allowed to be used by adults according to the FDA. The FDA is also considering allowing full-size doses of Moderna's vaccine for teenagers and half-size shots to children aged 6-11 in some countries.
According to U.S. Health officials, more than 30,000 children under 5 years old have been admitted with Covid-19. Nearly 500 coronavirus-related deaths have been reported in this age group.