Where can I find information on how my state is prioritizing vaccinations, and when it will be my turn?
FDA has issued, or is considering, Emergency Use Authorization (EUA) for some COVID-19 vaccines. What exactly is an EUA? What is required for FDA’s issuance of an EUA?
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Emergency Use Authorization (EUA) gives the FDA Commissioner authority to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by (Chemical, Biological, Radiological or Nuclear (CBRN) threat agents when there are no adequate, approved, and available alternatives. Thus FDA may issue an EAU if:
• CBRN agent referred to in the March 27, 2020 EUA declaration by the Secretary of HHS (SARS-CoV-2) can cause a serious or life-threatening disease or condition.
• Based on the totality of scientific evidence available, including data from adequate and well-controlled trials, if available, it is reasonable to believe that the product may be effective to prevent, diagnose, or treat such serious or life-threatening disease or condition that can be caused by SARS-CoV-2, or to mitigate a serious or life-threatening disease or condition caused by an FDA-regulated product used to diagnose, treat, or prevent a disease or condition caused by SARS-CoV-2.
• The known and potential benefits of the product, when used to diagnose, prevent, or treat the identified serious or life-threatening disease or condition, outweigh the known and potential risks of the product.
• There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition. If these criteria are met, under an EUA, FDA can allow unapproved medical products (or unapproved uses of approved medical products) to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by threat agents.
I’ve read that the cold-chain temperature requirements of vaccines that are closest to roll-out limit that amount of time that they are “fresh” – and that two doses will be required. Can you provide more information on this?
There are three vaccines that have undergone late-stage clinical trials [link to Vaccines 101] and are closest to or have received FDA authorization. Following are the dosage and temperature requirements for these:
· Pfizer. The two-dose vaccine to be received about 21 days apart received a recommendation for FDA EUA approval from its vaccine advisory committee on December 10. The biggest challenge will be storage and distribution: Due to the low-temperature storage conditions (-94), Pfizer has developed temperature-controlled thermal shippers utilizing dry ice to maintain recommended temperature conditions of -70°C±10°C for up to 10 days. If the vaccine is stored in refrigerated (2 – 8°C) conditions, it can be stored for up 5 days. Once thawed and stored under 2 – 8°C conditions, the vials cannot be re-frozen. Read Pfizer’s plan. Once in the refrigerator, the vaccine must be used within 5 days.
· Moderna. Two-dose vaccine – people will need to receive two doses about 28 days apart. The biggest challenge will be storage and distribution: Vaccine can be shipped at -20C (-4F) and stored for up to 6 months at that temperature. However, once thawed and in the refrigerator (2 – 8°C), the vaccine can be stored for up to 30 days. (Under FDA EUA consideration in December 2020.)
· AstraZeneca & Oxford University. Two-dose vaccine – people will need to receive two doses. Storage: The AstraZeneca vaccine can be transported and stored at refrigerator temperatures (2 – 8° C), which makes this vaccine much more accessible than the others.
Since we are in a critical infrastructure business, I’ve heard talk that our access to the vaccine is right around the corner. What do you see as realistic timing /expectations – recognizing that this is a fluid situation?
This is a fluid situation, and it is one in which the states will be making the priority determinations. But the expectation is that most states are likely to follow the recommendations that were made by the CDC Advisory Committee on Immunization Practices (ACIP) in a November meeting — a phased-in process, prioritizing healthcare workers and long-term care facility residents. The first phase of the ACIP proposal then includes vaccination essential workers followed by adults with igh-risk medical conditions and those over 65.
Although Pfizer is conducting surveillance studies in this area, there are currently insufficient data to make conclusions about the vaccine's safety in pregnant and lactating women. According to the Pfizer/FDA Briefing Document, Pfizer studies will be submitting plans for a clinical study to assess safety and immunogenicity in pregnant women and has proposed active surveillance studies designed to monitor vaccination during pregnancy within populations expected to receive the vaccine under EUA.
While noting the lack of available data on the safety of COVID-19 vaccines in pregnant people, CDC states, “Observational data demonstrate that while the absolute risk is low, pregnant people with COVID-19 have an increased risk of severe illness, including illness resulting in ICU admission, mechanical ventilation, or death. Additionally, they might be at an increased risk of adverse pregnancy outcomes, such as preterm birth.”
Given that, however, CDC notes that if a pregnant woman is among a group recommended for the vaccine (e.g., healthcare personnel), she may choose to be vaccinated. While a conversation with their healthcare provider could be helpful, it is not required prior to vaccination. In making the decision, the following considerations are recommended: the level of COVID-19 community transmission, the patient’s personal risk of contracting COVID-19, the risks of COVID-19 to the patient and potential risks to the fetus, the efficacy of the vaccine, the side effects of the vaccine and the lack of data about the vaccine during pregnancy.
If a person who has received the COVID-19 vaccine begins showing symptoms of the virus, should they be allowed to work, under the assumption that the symptoms are simply a reaction to the vaccine? Or should they be excluded?
If a person who has been vaccinated shows symptoms, TAG recommends that they be excluded from work. There is overlap between post-vaccination symptoms and those of the virus, so the two cannot be differentiated. It also is possible that the person could have been infected just prior to being vaccinated, so would have the virus and be infectious to others.
TAG recommends that any symptomatic persons be tested, as only the virus itself, not the vaccine, would cause a positive result. As stated by CDC, “Vaccines currently in clinical trials in the United States won’t cause you to test positive on viral tests, which are used to see if you have a current infection.” However, this is not true of antibody tests (which indicate you had a previous infection), as the immunities developed in the body through the vaccine may result in a positive.
The most common reaction to the Pfizer vaccine has been injection site reactions (84.1%), with other generally mild to moderate symptoms including: were fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%). Severe adverse reactions occurred in 0.0% to 4.6% of participants, were more frequent after Dose 2 than after Dose 1, and were generally less frequent in adults ≥55 years of age (≤2.8%) as compared to younger participants (≤4.6%).
Among adverse events of particular interest, which could be possibly related to the vaccine, lymphadenopathy was reported in 64 participants (0.3%): 54 (0.5%) in the younger (16 to 55 years) age group; 10 (0.1%) in the older (>55 years) age group; and 6 in the placebo group. The average duration of these events was approximately 10 days, with 11 events ongoing at the time of the data cutoff.
On Sunday, December 20, CDC’s Advisory Committee on Immunization Practices (ACIP) updated its vaccine guidance to further define priority groups. Following healthcare workers currently being vaccinated, ACIP recommends that frontline essential workers and people ages 75 and older be next in line as Phase 1B.
- Frontline essential workers are defined as firefighters, police officers and workers in education, food and agriculture, manufacturing, corrections, the U.S. Postal Service, public transit and grocery stores. This phase consists of about 49 million people.
- Following that, Phase 1c is recommended as including additional essential workers as those in transportation, food service, shelter/housing (construction), finance, information technology, energy, media, legal, public safety (engineers) and water/wastewater industries.
Interestingly, ACIP divided food workers — putting food and ag, manufacturing and grocery in Phase 1B and foodservice into 1c. So this is an area of which the industry should be aware.
If the CDC director accepts ACIP’s recommendation, the CDC will provide more guidance on how to implement each phase. Ultimately, individual states will determine their prioritization strategies for vaccine distribution although many will follow CDC’s guidance.
It is important to continue to wear a mask and continue all other COVID protections because, at this stage we don’t know if the vaccine will prevent transmission of the virus. That is, if you get exposed to COVID-19 after being vaccinated, you may still be able to be infected, though probably asymptomatically and for a short period, thus, you may still be able to transmit it to others. You also could have been infected before you were vaccinated, which would make it possible to transmit the virus to others.
Also, CDC states that experts need to learn more about the protection that COVID-19 vaccines provide under real-life conditions before deciding to change recommendations on steps everyone should take to slow the spread of the virus that causes COVID-19. “There is not enough information currently available to say if or when CDC will stop recommending that people wear masks and avoid close contact with others to help prevent the spread of the virus that causes COVID-19.”
With no studies having indicated that a person who has had COVID should not be vaccinated, and no definitive knowledge of if, or how long, immunity may be conferred by having had the virus, the recommendation is that those who had the virus should be vaccinated.
According to the December 13 CDC MMWR (Pfizer) and December 20 CDC MMWR (Moderna): “No specific safety concerns were identified in subgroup analyses by age, race, ethnicity, underlying medical conditions, or previous SARS-CoV-2 infection.” Additionally, a detailed summary of safety data, including information on reactogenicity, also is available at CDC.
When will we begin to see results of the vaccination having an impact our ability to return to a “normal” mask-less, non-distancing lifestyle?
At this stage we just don’t know but would expect that it will be at least another 6-9 months based on what we do know about COVID-19 and viruses in general.
It will depend on a number of factors, including the efficacy of the vaccine given in the greater numbers; how much immunity the vaccine provides and how long it lasts; and how quickly we’ll be able to get to a level of vaccination and immunity that significantly reduces the rate of spread – about 70-80%.
With some people having viral symptoms following a COVID-19 vaccination, how do we know if the person has the virus or is reacting to the vaccine? And when should they return to work?
Because we cannot differentiate between a vaccine reaction and the actual disease, TAG recommends that businesses take a cautious approach, assuming the symptoms are COVID based, for the protection of other employees and the business as a whole. That is:
- Any employee who has symptoms associated with COVID-19 should stay home for 10 days following system onset even if the employee was recently vaccinated and suspects that the symptoms are due to the vaccine.
- If symptoms following a vaccination resolve sooner without the aid of medication, the employee can return to work sooner if a COVID-19 PCR test is taken and returns negative.
- Other employees who experience COVID-19 symptoms but were not recently vaccinated may return to work when symptoms have resolved for 24 hours if it is at least 10 days post symptom onset or they have a negative test/medical assessment.
Additionally, because there may be some operational impact if a high percentage of your employees would have post-vaccination symptoms, TAG recommends that employee vaccinations be staggered as much as possible.
The country overall is doing very well in reducing cases, but we are not out of woods when it comes to the variants – and, given that community case rates are still relatively high in many parts of the US, bringing back symptomatic people who may, indeed, have the virus can increase the risk of workplace transmission. As vaccination rates continue to increase, we expect to see a slow and steady reduction in the national case rate. Right now, we are in a period of this pandemic where more infectious variants are becoming the predominant strains while vaccination rates (and some natural immunity from previous infections) are increasing. We are closely watching for rapid surges in cases over the next month that could signal the impact of these new (B.1.17, B.1.153, P.1, and others) emerging variants.
Does an employee who has been vaccinated need to quarantine if they are exposed to a person with COVID-19?
According to CDC’s new guidance of February 10, with which TAG agrees:
Vaccinated persons with an exposure to someone with suspected or confirmed COVID-19 are not required to quarantine if they meet all of the following criteria:
- Are fully vaccinated:
– ≥2 weeks following receipt of the second dose in a two-dose series
– ≥2 weeks following receipt of one dose of a single-dose vaccine
- Are within 3 months following receipt of the last dose in the series. (This is due to the newness of the vaccines and the studies still being conducted on long-term efficacy.)
- Have remained asymptomatic since the current COVID-19 exposure. If the person does have symptoms, follow the TAG recommendations discussed here.
Should someone who has been vaccinated, still be tested for COVID-19 if they are symptomatic or part of regular surveillance testing programs?
Yes – according to the same CDC guidance: “At this time, vaccinated persons should continue to follow current guidance to protect themselves and others, including wearing a mask, staying at least 6 feet away from others, avoiding crowds, avoiding poorly ventilated spaces, covering coughs and sneezes, washing hands often, following CDC travel guidance, and following any applicable workplace or school guidance, including guidance related to personal protective equipment use or SARS-CoV-2 testing.”
TAG agrees with this guidance because vaccines are not 100% effective and therefore testing someone for active infection remains a key strategy to reduce the risk of transmission. It’s also important to stress that the currently authorized mRNA vaccines are extremely effective at preventing moderate to severe illness and should significantly reduce the likelihood that someone would test positive for an active infection after they’ve been vaccinated.