Allied’s trusted physicians talk COVID-19 vaccine, addressing questions, rumors, concerns, and why this vaccine is the only way to end the pandemic.
By: Rachel Levene, PhD Candidate in Molecular Microbiology at Tufts University School of Medicine and daughter of Dr. Eric Levene, Chester Pediatrics.
We’ve all seen the wonderful news about Pfizer’s and Moderna’s COVID vaccine trials – preliminary estimates of greater than 90% efficacy. I, too, am extremely excited and hopeful, especially since I am a participant in Pfizer’s trial. I’m here to break down what this all means and when we might actually be able to roll up our sleeves and get vaccinated.
How do these vaccines work?
Pfizer’s and Moderna’s vaccines were made using new vaccine technology called mRNA. Their vaccines are a message that encodes the instructions for our cells to make part of the protein on the surface of SARS-CoV-2 (the virus that causes COVID-19). Even though the cell is making a viral protein, it cannot give anyone COVID-19 as the virus needs all its proteins to cause infection. The thought is that the immune system will make antibodies against this protein, much like what happens when someone gets naturally infected. The thought is that these antibodies will neutralize SARS-CoV-2 before it enters any cells and causes illness. Both require two doses, spaced three-four weeks apart.
One challenge of this new vaccine technology is how it is stored and shipped. mRNA is notoriously unstable and it needs to be kept at ultra-cold temperatures. Pfizer’s vaccine needs to be stored at -104°F, something regular freezers simply cannot do. Moderna’s can be stored for a limited period of time in a regular freezer and/or fridge. This presents a shipping problem and problem for distributing the vaccine in areas that do not have major medical centers that have access to ultra-freezers. Both companies and the government are working on distribution plans and how long the vaccines can remain stable in regular fridges and freezers
What is vaccine efficacy?
The trials are blinded, meaning that neither the participant nor the study team knows whether a participant got the actual vaccine or a placebo (saltwater injection). Both are slated to last two years – meaning that participants are followed for two years to see if they develop confirmed COVID-19 and to look at their immune response to the vaccine. The trials are designed to be able to make vaccine efficacy estimates before the two-year mark. Vaccine efficacy is statistics – making predictions about how well the vaccine prevents illness based on numbers. After a certain number of events (COVID-19 illnesses) in the participants (deemed the endpoint), some statistical models are applied to determine how effective the vaccine might be. Based on these models, a certain number of cases among the participants, and how these cases are split amongst the vaccine and placebo group a certain percentage of efficacy can be calculated.
The trials are also designed for an independent monitoring board to take a “sneak peek” after a fewer number of cases. This is called an interim analysis. What we just learned about were these. Both trials had about 90 cases of COVID-19 in the participants and ~90% of these were in the placebo group, hence the greater than 90% efficacy estimate. While 90 cases do not seem like a lot in trials of 30,000-44,000 people, it is a lot for an event-driven vaccine trial. The primary endpoints are around ~150 cases, which based on current upticks in cases in the country should not take long to get to. While this seems like few, based on statistical modeling this is all we need to see if there is an efficacy over 60%.
What do we still not know?
The news was released by a press release, so no independent scientists have actually reviewed the data yet nor has the data been made public. Scientists, including myself, still have a lot of questions.
- How well does the vaccine prevent severe COVID-19? If the vaccine does not completely prevent illness altogether, is someone who is vaccinated less likely to need to be admitted to the hospital, need intensive care? We know this is the case for influenza vaccines. Moderna has said that 11 of the cases were severe and none of these were in the vaccine group – which is good news. Even if the vaccine does not prevent illness altogether but still prevents severe illness, it will greatly reduce the impact on our healthcare system.
- Does the vaccine prevent asymptomatic infection? We know that people can spread SARS-CoV-2 and never feel sick. It would be helpful to know if the vaccine prevents this, as it provides indirect protection to others. It is still possible to have a vaccine that prevents disease and illness but not an infection. Since the trial was primarily set up to look for illness as endpoints, this question may be harder to answer.
- How well does the vaccine work in the elderly and children? Both trials have participants over 65. There is some evidence to suggest that the elderly have weaker responses to vaccines, including the flu vaccine, and need a higher dose. The Pfizer trial is unique in that it includes children ages 12-18. This is so important because children may respond differently to the vaccine. It may take some time until the vaccine efficacy can be evaluated in children under 12.
- How long does any protection last? This is hard to know because only time can give us this answer. It is still too early to say if we will need to be vaccinated every year, need a booster every couple of years, or have lifelong immunity.
What’s next and when can we expect to get vaccinated?
The FDA has told us that they will not authorize a vaccine for use unless it shows at least 50% efficacy. The good news is that early data from both trials exceed this. The next step is for them to submit their data to the FDA for emergency use authorization (EUA). This does not mean full FDA approval but that given the circumstances, the FDA thinks the benefits outweigh the risks. This is still a very high bar. Thus, the FDA wants at least two months of safety data from the trial participants. Additionally, there will be systems in place to monitor any adverse events, should there be any, as people get vaccinated. As a Pfizer participant, I have seen first-hand that safety is the highest priority. Additionally, they must show that it can manufacture the vaccine consistently and with the highest quality standards. If the FDA gives EUA, you can be sure their experts think it’s safe.
If they have approval, there will be very limited doses at first. Many organizations and agencies have come up with early distribution plans. Healthcare professionals and first responders will likely be first followed by essential workers and those with the highest risk like those in congregate care facilities. The general public will likely not be able to be vaccinated until the spring of 2021. Until then it is so important to continue wearing a mask/face covering, practicing physical distancing, and not gathering in groups especially indoors. And be sure to get your flu shot!
By: Kerry Fierstein, MD Pediatric Health Associates (Plainview, New York)
Dear Parents & Caregivers,
Measles outbreaks in Brooklyn and Rockland have put public health on the front page of our newspapers. A disease which had been declared eliminated from North America in 2002, is once again scaring parents, doctors and government officials.
Things to know:
-When Measles vaccine rates in a community fall below 95%, measles virus comes back.
-Measles is very contagious and it is difficult to avoid exposure when measles is in the community.
-Children with measles commonly have serious complications.
-There is no treatment for measles, but we can prevent it with the measles vaccine.
-Measles vaccine is safe and effective.
-Measles vaccine is given as part of the MMR (measles, mumps, rubella) or the MMRV (measles, mumps, rubella, varicella.)
-Measles vaccine is recommended at 12 months and again at 4-6 years of age. After the first dose 93% of children are immune to measles. After the second dose 97% of children are immune to the measles.
– The second measles vaccine may be given as soon as 28 days after the first one and still fulfill all school requirements.
-Infants 6-12 months of age who are going into high-risk areas may receive an early dose of vaccine, but would still need two more doses after one year of age.
-There are measles outbreaks in Brooklyn (mostly Williamsburg and Borough Park) and Rockland with isolated cases surrounding those areas. Westchester cases are starting to rise.
-Travel outside of the US is considered high risk.
Things to do:
-Vaccinate your infant for measles on time, at 12-15 months.
-Tell your pediatrician if your child is traveling internationally (or visiting a local area of outbreak.) If the child is 6-12 months, an early MMR should be given. If the child has only had one vaccine, it may make sense to give the second vaccine early.
– Speak out against anti-vaccine propaganda in social media. We can not allow the anti-vaccine minority to drown out well-established science and put our children at risk.
To learn more about the Allied Physicians Group vaccine schedule visit, https://alliedphysiciansgroup.com/what-to-expect/
This week’s story of a boy on Long Island with bacterial meningitis who required ICU care brought out raw emotions in all of us. We can’t help but empathize with the family, and think “what if this was my child?” The important take-away message is that certain infections are very serious and prevention is the best course of action, and that means vaccines.
Pediatricians are vaccine experts and most of us consider it our mission to protect your child by vaccinating him or her. We get frustrated when we need to convince parents of the need to vaccinate their children. In part, this is due to the effectiveness of vaccines in eliminating many life-threatening diseases. Unfortunately, if enough parents decide not to vaccinate their children, many of the diseases of the past will become all too real a part of our children’s futures.
Diseases which used to strike fear in the hearts of parents and pediatricians have all been virtually eliminated by vaccines.
Measles was virtually unseen in the United States for many years until a Disney World outbreak in 2014. This deadly disease is a major problem worldwide, killing over 700,000 children per year. There is a current outbreak of over 50 cases of measles in Minnesota due to fear of vaccines.
Polio infected nearly 60,000 children, causing more than 3,000 deaths in the United States, at the height of the 1952 epidemic. Since the polio vaccine was introduced, polio has been completely eliminated in North America.
Pertussis, also known as whooping cough, has seen a resurgence due to a decrease in vaccination rates. The pertussis bacteria produce weeks of coughing spasms that cannot be cured with an antibiotic. In infants, pertussis can lead to death.
Haemophilus Influenza B was the most common cause of meningitis and epiglottis in young children before the HIB vaccine came out in1983. The HIB vaccine has decreased invasive Haemophilus disease by over 95% and saved the lives of thousands of children.
Pneumoccocus is a very common cause of meningitis, pneumonia and sepsis (an infection of the blood and organs.) Since the introduction of the Prevnar vaccine in 2000, rates of serious pneumococcal disease have decreased 80%.
Meningococcus causes meningitis in infants and adolescents. The Menactra vaccine, which contains 4 strains of this organism, is so effective in preventing disease that New York State requires students be vaccinated before 7th and 12th grades. Many colleges are now requiring all students be vaccinated. A fifth strain, MenB for short, has emerged on college campuses in the last few years. A vaccine for Men B was approved for use in the United States about 2 years ago. There is no recommendation for routine use of this vaccine. Your pediatrician will be happy to discuss these recommendations and why you should or should not need the vaccine.
Human Papilloma Virus, commonly acquired during the teenage and college years is inextricably linked to cervical cancer. HPV vaccine has been available in the U.S. for over 10 years. In addition to preventing the strains of HPV associated with cancer, it also prevents the strains associated with genital warts.
Your pediatrician is your best source of vaccine information. Talk to your pediatrician about the vaccines that are available and make sure your child is safely protected against all vaccine preventable illnesses.
Measles is a highly contagious virus and is spread by air through coughing and sneezing. Measles usually starts with fever, runny nose, red eyes and sore throat. It is followed by a rash that spreads over the body.
“Although usually a self-limited illness, children younger than 5 years of age and adults older than 20 years of age are more likely to suffer from measles complications. Ear infections occur in about one out of every 10 children with measles and can result in permanent hearing loss. As many as one out of every 20 children with measles gets pneumonia, the most common cause of death from measles in young children. About one child out of every 1,000 who get measles will develop encephalitis (swelling of the brain) that can lead to convulsions and can leave the child deaf or with intellectual disability.For every 1,000 children who get measles, one or two will die from it. Measles may cause pregnant woman to give birth prematurely, or have a low-birth-weight baby.” (https://www.cdc.gov/measles/about/complications.html)
Please make sure your child(ren) are vaccinated at the recommended time. If your child is exposed to a person with Measles please call your provider as soon as possible.
California has been experiencing a Whooping Cough outbreak, with hundreds of new cases, and the deaths of 10 infants in the last year. Whooping cough, also known as pertussis, is a highly contagious respiratory illness that causes violent coughing. The Chicago Tribune (1/19, Stat) reports that whooping cough has made a comeback in Chicago as well. Health officials in Chicago are urging adolescents and adults — especially those who interact with newborns — to get a whooping cough booster shot.” In NYS all 6th graders are required to get a Tdap (Tetanus and Pertussis) booster, but most adults are no longer protected against whooping cough. It is recommended that all parents with infants get a booster. Pregnant moms are offered the vaccine after delivery in many hospitals. Dads should contact their primary care physician.