COVID Vaccine Update
With three COVID-19 vaccines approved under Emergency Use Authorization (EUA), what is the latest regarding additional vaccine approvals? Let us look at the latest developments and related news.
What vaccines are next in the queue?
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Based on messenger RNA technology, the Pfizer and Moderna vaccines have now had over 102 million doses distributed and over 52 million Americans have received one or both required doses and more vaccine help is likely on the way.
The FDA reviewed and approved Johnson & Johnson’s (J&J) Adenovirus Vector vaccine on February 26, 2021. Most notably, this product will be a single-dose vaccine that can be stored under normal refrigeration for two months. From those aspects alone, it could be considered a game-changer. It would fuel the practicability of reaching challenging demographics, such as rural communities, via mobile clinics and vaccine fairs.
J&J has committed to providing 100 million doses of its vaccine by June 2021 as part of an agreement with the U.S., which paid J&J $1.456 billion to help fund the development. The pact carries an option for the U.S. to buy 200 million more doses. Shipping started March 1, but only 4 million doses will be initially available.
Adenovirus Vector vaccines leverage an existing virus that is altered to produce the SARS-CoV-2 protein. This process is intended to elicit an immune response to the virus. While this vaccine is intended to develop a more robust immune system response in patients, the drawback is that the immune response may not be effective among patients with existing robust immune systems, particularly those with prior adenovirus exposure.
The primary focus for most is the efficacy comparison between the vaccine options. A vaccine touting a 90% efficacy is exceptional, which we have with the two messenger RNA vaccines from Pfizer and Moderna. With the ongoing focus on efficacy, what about that 66% efficacy with the J&J vaccine? We need to distinguish between prevention of symptomatic COVID-19 and focus on severe COVID-19 symptoms that lead to hospitalizations, death, and further transmission.
As you can see from the table above, Pfizer shows 89% efficacy against “severe” COVID-19 symptoms, while Moderna clocks in at 100%. Depending on the study, J&J is touting between 85% to 100% against protection from hospitalization and death, 28 days after vaccination. Perhaps it is not a magic bullet preventing all symptoms but is highly effective at preventing hospitalization and death after just one dose. A single dose of the messenger RNA vaccines probably provides 80% efficacy, based on data reviewed.
And we must also consider that the messenger RNA vaccines held their trials earlier in the pandemic, versus the original strain. One can hypothesize that the “underperformance” of the J&J vaccine is attributable to the emergence of COVID-19 variations we have seen over the last few months.
What about a vaccine for children?
Pfizer’s vaccine is authorized for individuals over 16 years and Moderna’s vaccine is currently authorized for over 18 years. Both companies have begun clinical trials for younger children. Keep in mind that young adults and kids are not typically at high risk for severe illness from COVID-19. There will likely be exceptions like individuals who are aged 16 and up with high-risk health conditions who may have the opportunity to get the vaccine sooner, as well as individuals aged 16 and up who are essential workers.
With any luck, a full pediatric vaccine will be available by late 2021. Children’s immune systems are very different from adults’, and their immune responses can be different at different ages, from infancy through the teenage years. Therefore, research on COVID-19 vaccines for ages 16 and up will need to be repeated with younger age groups.
Both Pfizer and Moderna recently began new vaccine trials including children as young as age 12. If they are successful, the data will need to go through FDA review. This process can take a while, especially for very young ages, which are usually tested last.
Meanwhile, Johnson & Johnson will test its vaccine in children and infants. The update surfaced from a briefing document ahead of the February 26, 2021, FDA advisory committee meeting, which led to the approval of the vaccine. J&J will first trial the vaccine in children age 13-17, then move on to adolescents and newborns.
PBMs have responded by placing age limits on the vaccines, to adhere to the FDA safety profile. Confidio does not recommend removing those age limits currently.
Areas of Hesitancy
Are there any lasting consequences from getting one of the COVID-19 vaccines?
Reviewing post-vaccine safety figures is continuing. We know that vaccines may have short-term side effects such as fatigue, headaches, fever, or muscle pain. We need to balance any short-term side effects from COVID-19 vaccines with the long-term effects of COVID-19 itself. Namely, fatigue, shortness of breath, prolonged cough, joint pain, difficulty with concentration, depression, hospitalization, and more. The virus is worth thwarting by receiving the vaccine when it is available to you.
The vaccines were developed too quickly, and I do not trust them.
Fears that the COVID-19 vaccines were rushed to market led to vaccine hesitancy. The FDA approved the first two vaccines based on novel mRNA technology. This new technology meant that the coronavirus did not have to be grown in eggs or cell culture to develop a vaccine, significantly reducing the production timeline.
Manufacturer collaboration with the federal government allowed the vaccines’ development sooner than normal conditions would dictate. Also, nationally distinguished experts reviewed the efficacy and safety data for the FDA (the Vaccines and Related Biological Products Advisory Committee) as part of the approval process for these vaccines. In this case, speed did not equal carelessness, as all necessary stages were taken in the manufacturing and review process.
I have read that the mRNA vaccines by Pfizer and Moderna will modify my genes?
mRNA technology has been studied for decades, even though we are seeing it in a vaccine for the first time. Enzymes rapidly destroy the mRNA once it is in your body’s cell. Subsequently, it does not stay in your body.
If you are concerned about mRNA technology, vaccines with other technologies are being developed and likely approved soon. Oxford/AstraZeneca and Johnson & Johnson developed vaccines using a virus that cannot replicate as a vector to carry the message to your body’s cells. Another vaccine by Novavax will use existing technology, using a recombinant spike protein along with an adjuvant to stimulate the immune system.
I have read that the vaccines could cause infertility or to avoid if I am pregnant.
There is no evidence that any of the COVID-19 vaccines could cause infertility or create harm for a developing fetus. Pregnancy is a potential risk factor for an increased likelihood of having serious COVID-19 complications. The coronavirus also carries a higher risk of miscarriage or stillbirth and warrants the need for vaccination to reduce these risks.
The CDC has developed a list of considerations for pregnancy concerns.