Q: What is the status of COVID-19 vaccine research in children and adolescents?
A: To date, Pfizer has enrolled children down to age 12 and submitted its EUA for vaccination indications down to age 16. Moderna is about to start a similar study, as is Janssen. Astra Zeneca has approval to enroll children in the UK, ages 5-12, but has not yet enrolled any children in the US. We anticipate that studies including younger children will begin soon.
Q: Any effects of COVID vaccine on pregnancy, the developing fetus, or infants?
A: No pregnancy related data have yet been released. Pregnancy and breastfeeding will probably not be contraindications to receiving COVID-19 vaccine; however, there is no safety data in the pregnant woman, her fetus or infants at this time. While these vaccines were not specifically tested in breastfeeding women, it is not likely (based on the mechanisms of action of the vaccines in US trials) that there would be any risk to the child.
Q: Are there any safety concerns with the new technologies being used in the development of COVID-19 vaccines?
A: There are no known additional risks of mRNA vaccines or lipid nanoparticles. Live attenuated viral vaccines, such as measles vaccine, induce an immune response that is similar to natural infection. mRNA vaccines, on the other hand, simply give the body instructions to produce one very specific part of a virus – in this case the so-called spike protein – to then induce an immune response. Because mRNA is broken down very quickly in the human body, to do its work it needs to be able to get into our cells, and so it is wrapped in a lipid nanoparticle. Once it gets into the cells to deliver the instructions, the mRNA breaks down very quickly. It does not get into the nucleus of the cell, or into our genes.
Q: How quickly after immunization does the vaccine protect the recipient, and how long does immunity last?
A: The current studies start counting cases for efficacy at 7 to 14 days after the second dose, which is likely how long it takes to get very high levels of neutralizing antibody. Only one manufacturer could potentially have a one-dose vaccine (Janssen). It is yet unknown how long immunity will last.
Side Effects and Safety Monitoring
Q: What side effects are noted to date with COVID-19 vaccine?
A: The side effects have been similar to other routine vaccines- sore arm, redness, fatigue, fever, chills, headache, myalgia, arthralgia. The side effects are temporary and mostly mild or moderate. Side effects may be worse after the second dose in some.
Q: Do we need to worry about MIS-C in kids receiving COVID-19vaccine?
A: One of the reasons to perform vaccine trials in children is to make sure that they do not have any side effects that are pediatric-specific. There is no known biomarker to predict an immune response that leads to MIS-C. It is also possible that protection from COVID-19 by vaccination will also protect against its sequelae, including MIS-C.
Q: What is the safety testing that has been done on COVID-19 vaccines?
A: The safety follow-up for COVID-19 vaccines is essentially the same that it is for all vaccine trials. The expectation for the adult phase 3 trials is 2 years of safety follow-up – longer than for most vaccines during development. It is impossible to know the very long-term safety profile of vaccines that have only been in humans for about 6 months. That said, no vaccines yet licensed have been found to have an unexpected long-term safety problem, that was found only years or decades after introduction.
Q: Should those who have had apreviousSARS-CoV-2infectionwait to get vaccinated?
A: It is expected that vaccination will be recommended regardless of prior infection. While vaccine supplies are constrained, vaccination of persons with recent prior infection may be delayed. The duration of protection after infection is unknown.
Q: Will there be a vaccine available for children before the 2021-22 school year?
A: This will depend on the results of the trials of the vaccine in adolescents and children that are planned or underway now. But based on the current pace of research, it is potentially achievable that we will have a vaccine for at least some age groups of children and adolescents before the 2021-22 school year begins.
Q: Will the vaccine be required for school entry?
A: When a vaccine is shown to be safe and effective in children, health authorities, including the CDC and the AAP, will make recommendations on when and how children should receive the vaccine. However, it is a state government decision which vaccines are required for school entry.
Q: Can COVID-19 vaccine beco-administered with other childhood immunizations?
A: Until we have a COVID-19 vaccine for children, we need to focus on getting children caught up and keeping them up-to-date on routinely recommended vaccines. Administration of the COVID-19 vaccine with other childhood or adolescent immunizations has not yet been tested. There are very few vaccines in which co-administration with other vaccines is problematic.
Q: Why do children need to be vaccinated?
A: COVID-19 can cause significant illness in children. In children for whom COVID-19 caused serious illness, half had an underlying condition, and half did not. This is similar to influenza. We need to vaccinate children because we do not know which children may be at higher risk of serious, possibly life-threatening illness. Children can also transmit the virus, including to more vulnerable adults who are in their family or in their school, so it is important that children be included in the vaccine distribution in order to reduce community spread.
Q: Would you still recommend continuing full precautions after vaccination?
A: Yes! We will need to continue to practice physical distancing, wearing cloth face coverings and masks, and using PPE during medical encounters for some time after the vaccine is introduced. It will be some time before there is evidence that the vaccines not only prevent illness in the person who is vaccinated, but also prevent them from transmitting the virus. Until then we will need to practice these public health measures.