Things have moved faster than normal, but we have done everything correctly. The FDA was able to approve an Emergency Use Authorization for Pfizer based on its good safety and efficacy profile. We have been very careful in monitoring safety and have taken no short cuts in evaluating the vaccines at Cincinnati Children’s. Almost 40,000 people enrolled in Pfizer nationwide, over 30,000 enrolled in Moderna and close to 30,000 for both Janssen and AstraZeneca. Thus, we will have a lot of safety data before the other vaccines are licensed.
The overall fatality rate for COVID is 2 percent to 3 percent. That rate might sound small, but if you apply it to the entire population it would equate to about 5 million to 10 million people who would die from COVID. That would entail a lot of human suffering and exact a huge emotional toll on families faced with losing loved ones.
No. Many people have no symptoms at all. If people are going to have symptoms, the most common have been soreness at the site of vaccination, headaches and fatigue. Some people have had body aches and rarely (less than 10%) people have had chills and/or a fever. If people are going to have side effects, they typically start 1-2 days after vaccination and last for 1-2 days. Some people have had more side effects with the second dose of vaccine but again the side effects are short lasting. One could think of the symptoms described above are a good thing as it is a sign that the vaccine is working. While we would prefer that no one who received the vaccine had any side effects, we think the benefit of protection against a potentially lethal virus FAR outweighs the possible risks of the vaccine.
Yes. The mRNA vaccines (Pfizer and Moderna) are not “live” vaccines and thus immunocompromised individuals are at no greater risk from these vaccines than any other person. While neither the Astra Zeneca nor Janssen vaccines use adenoviruses that can grow in our body, they are “live”. Thus, while we have no reason to think either the Astra Zeneca or Janssen vaccines are of increased risk to people with immunocompromising conditions, it would be best to discuss with you doctor if one type of the COVID-19 vaccine may be better for you.
This is a hoax. It is absolutely untrue.
None of the vaccines contain human cells. The Pfizer and Moderna vaccines are pure mRNA that was made in the lab. This process does not use any cells at all. The AstraZeneca and Janssen vaccines use an adenovirus to bring the spike protein gene to our cells. Viruses need to grow in cells. After the adenovirus used in the AstraZeneca and Janssen vaccines are grown, the virus is collected from the cells and purified. So there ONLY is virus, NO human cells, in the AstraZeneca and Janssen vaccine. The initial cell line for the AstraZeneca vaccine came from human embryonic kidney cells. However, those cells were obtained over 60 years ago. There are NO human cells in the finished product of either the AstraZeneca or Janssen vaccine.
While masks, social distancing and hand hygiene can prevent 85 percent of COVID cases, vaccines are key to returning to the lifestyles and workplaces we enjoyed before the pandemic.
No. The vaccines only contain a piece of the virus. Depending on the vaccine, it either contains the piece of the virus that tells our body to make the spike protein or it contains the spike protein itself. The spike protein is what the virus uses to attach to our cells and start an infection. The body then makes antibodies to the spike protein, which protect people against COVID-19 should they be exposed to the virus. The vaccine does not contain the whole virus, so it is impossible to get COVID-19 by getting vaccinated.
Vaccines are going to be critical to get rid of the pandemic. It’s much safer to get a vaccine than to contract COVID-19.
As of Dec 31, 2020, more than 2.2 million kids in the United States have been infected, and thousands of them have been hospitalized with COVID-19. At least 180 previously healthy kids have died of COVID. The vaccine is important for the health and safety of children, but also to prevent them from spreading the disease to adults such as parents, grandparents, and teachers. Vaccines are going to be critical to get rid of the pandemic. It’s much safer to get the vaccine than to contract the disease.
We strongly advocate that every child over 6 months old get a yearly flu shot. Currently, there is no vaccine against COVID authorized for children. However, when a COVID vaccine is authorized for children, we will advocate that every eligible child be vaccinated against COVID.
While we have not yet specifically tested COVID-19 vaccines in pregnant women, there is no reason to suspect that the COVID-19 vaccines currently being tested would be of risk to the mother or her baby. The American College of Obstetrics and Gynecology (ACOG) has recommended; “that COVID-19 vaccines should not be withheld from pregnant individuals who meet criteria for vaccination based on ACIP-recommended priority groups”. Additionally; “COVID-19 vaccines should be offered to lactating individuals similar to non-lactating individuals”. COVID-19 vaccine testing in pregnant women is planned and likely will start in the spring of this year.
Are there concerns in the medical community about how polarized the public is about all science especially prevention including vaccines?
We are concerned about the general breakdown in the trust of science and how Public Health measures are being viewed as political issues instead of safety issues. However, we need to keep up the fight and continue to be strong advocates for the health of children, particularly preventive medicine such as vaccines. If we don’t keep up the campaign to educate and inform parents, we will be putting the health of children at risk.
How do you discuss the potential long term risks that can’t be known yet due to the vaccine creation timeline?
All the vaccines are targeting the spike protein. The mRNA vaccines are using mRNA that is degraded soon after it is translated into spike protein. So, there should not be any long term effects of the mRNA. The Astra Zeneca vaccine is using an adenovirus that is replication incompetent, meaning that the virus can’t live and grow in us. The Sanofi and NovaVax vaccines are protein vaccines, very similar to the flu vaccine. The end result is that while the technology is new, there is no evidence to indicate there is long term harm from the vaccine candidates.
Currently, Pfizer is listed as -70C while Moderna is -20C. Astra Zeneca is refrigerated. But, I think companies will be looking at the ability to safely store the mRNA vaccines at warmer temps. I think there will be a workable solution as to the storage requirements.
Pfizer said they are currently looking at the stability of the vaccine at warmer temps. My guess is that we will find that the Pfizer vaccine will have storage requirements similar to Moderna. However, we need to test to be sure.
What about patients who have tested positive whether symptomatic or not OR have positive antibodies – is there a plan whether they will be able to get the vaccine?
Good question. That still needs to be decided. From small scale studies in adults, the frequency and type of side effects were the same whether or not you had already had COVID.
The clinical trials for children likely will start in late winter- early spring. As for children we are doing “Immunological bridging studies”, the numbers will be smaller and results available sooner (maybe within 2-3 months of enrolling). Thus, we still think it possible that we will have licensed vaccines for at least some pediatric age groups before the 2021-2022 school year.
Currently, the youngest is 12 years of age. However, we have been sent protocols from 2 different sponsors with the age going down to 5 years of age. Some companies have talked about going down to 12 months or less but we have not seen those protocols yet.
Experts believe about 60% of the population will need to be vaccinated. Be a part of the solution!
It is amazingly effective! The trials started in July 2020, and have shown the vaccine to be 94-95% effective in preventing COVID-19 disease. The first to hit the market will be 2 injections, likely 1 month apart. The Pfizer vaccine demonstrated 54.4% efficacy after the first dose!
No. We know COVID can have a terrible, unpredictable course (short-term and long-term) in both healthy individuals and those with pre-existing conditions. If we forgo the vaccine and try for natural herd immunity at our current pace, 1.4-1.7 million Americans will die due to COVID-19 before we achieve adequate herd immunity.
As far as vaccine trials go in general, the major side effects are expected to surface in the first 4-8 weeks (which we’ve passed). The most common effects noted in the Pfizer and Moderna trials were soreness at the injection site (4-11% of recipients), muscle soreness (4-9%), fatigue (5-9%), and fever (6%). All resolved in 1-2 days.
Yes! The Pfizer vaccine, for example, enrolled 45,000+ people, of whom 25,000+ people got the actual vaccine. This is on par with all other non-COVID vaccine trials, who usually enroll 30,000+ people.
Also keep in mind that other medicines (pills) are approved after only being tested in much fewer people (~1500 people, for example. Vaccines are the most rigorously tested therapies, including the COVID vaccine.
The science itself was not rushed – the only parts bypassed were the time usually required to fundraise and the time usually spent waiting in line for the papers to be reviewed by the FDA and other regulatory administrations.
No. The mRNA enters the cell but NOT the nucleus, were your DNA lives. It gives our cells instructions for how to make a harmless protein that is unique to SARS-CoV-2. It lasts just long enough to teach the cell how to encode the protein, and then the mRNA is destroyed. Then, if you’re subsequently infected, your body recognizes the virus should not be there and the immune response is triggered to fight it off effectively.
This is an amazing technology that has been in development for many years, but was able to be accelerated due to everyone’s focus during the pandemic.