Who is working on the COVID-19 vaccine?
More than 150 coronavirus vaccines are in development across the world. Two companies have reported successful reports from their first vaccine phase 3 (large group) trials: Pfizer and Moderna [10,12].
What kind of vaccine trials were these?
Both Pfizer/BioNTech and Moderna’s vaccine trials were randomized, placebo-controlled, observer-blind, dose-finding studies. This means they had a control group (placebo) and vaccine group, and also are testing different doses of the vaccine on different ages and demographics for efficacy, or how well it works. More than 30,000 people have been in the Phase 3 trials .
What did the Pfizer and Moderna study results show? Were there COVID cases in people who got the vaccine?
Pfizer reported that 95% of the COVID cases tracked in the study were in the placebo (control) group . This is an amazing and statistically significant finding.
Initial expectations to proceed with the vaccine trials are that a COVID-19 vaccine would prevent disease or decrease its severity in at least 50% of people who are vaccinated. Both Pfizer and Moderna are reporting 93-95% effectiveness or better .
How will the vaccine be given?
The COVID-19 vaccine will most likely be two intramuscular deltoid (upper arm) injections 21 days apart . This is similar to most other vaccines such as Hepatitis B, pneumococcal, MMR (measles, mumps, and rubella), and DTaP (diptheria, tetanus and pertussis) vaccines. See common multi-dose vaccine schedules here . Oral and skin patch vaccines are in development, which may aid delivery, administration and acceptance of the vaccine .
Were these vaccines rushed?
Most vaccines in use today have taken years and, in some cases, decades to develop. For this vaccine, governments and companies have dedicated substantial funds and personnel into companies and institutions developing vaccines. These current vaccines were developed over 10 months with unprecedented focus, collaboration and financial support .
Given the urgent need, some vaccine developers are compressing the clinical process for the SARS-CoV-2 (COVID-19) vaccine by running trial phases simultaneously. The approval process can also be expedited for favorable trial results .
Is this vaccine safe?
Regardless of vaccine urgency, the vaccines are still proceeding through the required stages of development. Phases 1, 2 & 3 of vaccine trials (animal, small group of people, large group of people) are maintained. Sometimes phases 1 & 2 can be combined. The steps of approval can be accelerated.
The CDC has stated: “The U.S. vaccine safety system ensures that all vaccines are as safe as possible. Safety is a top priority while federal partners work to make a coronavirus disease 2019 (COVID-19) vaccine(s) available.” You can read more here about the CDC’s plans for specific tracking and monitoring for any issues with the vaccine .
What are the COVID-19 vaccine’s side effects?
A small percentage (4-10%) of those who received the COVID-19 vaccine experienced symptoms such as body aches, fatigue and headaches. It’s similar to what people might experience after a flu shot and is a sign the vaccine is working to create an immune defense. 19,000 participants have been followed and monitored for side effects for at least 2 months . Initial trial participants will be fully followed for 12 months following vaccine administration.
I heard about Bell’s Palsy as a side effect. Did that happen?
Yes, there were 4 cases of Bell’s Palsy in the vaccine group. The FDA stated that the observed frequency of reported Bell’s palsy in the vaccine group is consistent with the expected background rate in the general population, and there is no clear basis upon which to conclude a causal relationship at this time. The agency is recommending surveillance for Bell’s palsy cases as the vaccine is deployed at scale.
I heard about bad allergic reactions after getting the vaccine in Great Britain. Did that happen?
Yes, there were 2 cases of severe allergic reaction in 2 people that carried Epi-Pens for severe allergies and received the vaccine. Health authorities in Great Britain stated that people with a “significant history of allergic reactions” should not be given the Pfizer/BioNTech coronavirus vaccine. People with a history of severe allergic reactions should check with their health care provider before receiving the vaccine.
Will the vaccine absolutely prevent the disease?
It’s not clear yet whether the vaccine would prevent infection altogether for all persons. Its intent and findings are that it makes severe illness from COVID-19 much less likely, as with the flu vaccine. Initial results show that there is dramatically less COVID-19 infection in the participants who have received the vaccine  but not enough data yet to state that it stops transmission between individuals.
How will the COVID-19 vaccine work?
The vaccines from Moderna and Pfizer both use a new approach studied in clinical trials for other viruses.
Both of the two companies’ vaccines do not use the COVID-19 virus itself, but use messenger RNA (M-RNA) genetic code rather than any part of the virus itself. m-RNA vaccines are different because they contain information about the infectious agent to give a body’s cells instructions to make a viral protein that can be recognized by the immune system. The vaccines deliver mRNA which directs cells to make pieces of the spikes that sit atop the coronavirus. Once the vaccine is in the body, the body’s immune system makes antibodies that recognize these spikes. If a vaccinated person is later exposed to the coronavirus, those antibodies should recognize and attack the COVID-19 virus [10,12]. Parts of the immune system are then programmed to maintain a defense and be able to stop COVID after the immunization.
Other companies are developing vaccines using other techniques — the Oxford/AstraZeneca vaccine is made from a harmless modified chimpanzee virus, which is the traditional route to using an inactivated virus.
What kind of participants are in the COVID-19 trials?
More than 30,000 participants are participating in the study. Pfizer trial participants are at 150 trial sites in 6 countries including 39 US states. Recognizing the disproportionate impact of the epidemic on underrepresented minority populations, vaccine developers for both Pfizer and Moderna enrolled 37 to 45%% of trial volunteers from diverse racial and ethnic groups, and included volunteers with stable HIV+, Hepatitis B & C, and other chronic diseases .
Moderna’s trials include more than 11,000 participants from communities of color, representing 37% of the study population, which Moderna said was similar to the diversity of the US population. This includes more than 6,000 participants who identify as Hispanic or Latinx, and more than 3,000 participants who identify as Black or African American.
Moderna stated it slightly slowed down the trial recruitment to ensure that they had a substantial representation of people of color. The vaccine performed well across all of the population groups .
How long does the COVID-19 vaccine protection last?
Vaccine researchers do not know how long the vaccine protection will last at present. They will be tracking participants for a total of 12 months after receiving the vaccine [10,13].
Who will get the vaccine first?
Phase 1 rollout of the vaccine will first be available for the 17-20 million healthcare workers and also essential workers (non-healthcare, such as Food & Agriculture, Transportation, Education, Energy, Water and Wastewater and Law Enforcement), persons with high risk medical conditions, adults 65+, and residents of extended care facilities/ nursing homes . There are several stages to vaccine rollout. Geographical area and other factors may also be considered.
Should my employer get me access to the vaccine? Do I need to get the vaccine to go to work?
The MNA feels that health care employers should make vaccines available to all health care workers (HCW) and all HCW should check their contract language for how vaccination is framed as part of the language around their working conditions.
What if my employer says the vaccine is mandatory?
MNA has a history of rigorously supporting vaccine initiatives. MNA feels that vaccines should not replace other worker protections, such as PPE and other infectious control measures. Please contact your labor representative for any concerns.
For any questions regarding this information sheet, you may contact Larissa Miller, Associate Executive Director of Nursing.
For more information, you can refer to the CDC’s “Frequently Asked Questions” regarding the COVID-19 vaccine.