President’s Corner December 2020
COVID-19 Persists…We Persevere
When I first wrote about the COVID-19 pandemic in the springtime, much was unknown about the virus, but many of us were hopeful that by this time of year, it would be in our past. Unfortunately, the pandemic continues unabated with a new surge of infections and deaths in most of the world. Despite the intensive scientific research on the disease, potential treatments and vaccines, we will probably be facing threats to our health and our old lifestyles well into 2021.
What are the ongoing implications for pilots? Some of the major ones include FAA medical certification policy, vaccine development and FAA policy on medical status after receiving a vaccine when available, international travel documentation requirements, preserving mental and physical wellbeing and keeping families healthy with travel and holiday celebrations.
Medical Certification – SFAR 118-2 Extensions
Regarding medical certification of pilots, the FAA has issued Special Federal Aviation Regulation (SFAR) 118 and two subsequent revisions which allowed for an extension of the expiration date of medical certificates and other training requirements. These included Special issuance Authorizations, for three months in the first two extensions and two months for the most recent one (except for pilots living in Alaska which is three months).
I participate in the ICAO CAPSCA committee as well as ICAO’s medical certification and aviation mental health working groups. The original alleviations allowing extensions of medical certificate duration, training and currency requirements were made in March 2020 with an expiration date of March 31, 2021. ICAO’s current position is that there will be no further alleviations granted, except under extremely unusual circumstances.
COVID-19 Vaccine Development Progress & FAA Vaccine Policy
Clinical trials to evaluate potential vaccines to prevent COVID-19 continue in the US, Canada and abroad. In the US after all the phases of clinical trials are completed assessing both safety and efficacy, a vaccine can receive full Food and Drug Administration [FDA] approval with licensing. FDA approval of one vaccine does not grant approval of other COVID-19 vaccines and each must be individually evaluated before full FDA approval for general distribution and use by the public.
FDA Emergency Use Authorizations (EUA’s) for large trials of vaccines are NOT full FDA approval. Even after approval, ongoing studies will still be conducted to ensure continuing safety of the vaccine. Over the last 10 days, the FDA granted EUA’s for both the Pfizer/BioNTech COVID vaccine and the Moderna vaccine based on preliminary safety and efficacy data in Phase 3 trials with potential public health benefits outweighing risks of releasing prior to full completion of the study. See the VRBP Advisory Committee document for full details on the Pfizer vaccine and the Moderna vaccine. Both use new technology for their mRNA vaccines.
Other companies working on different vaccines (protein subunit vaccines and vector vaccines) may have announcements in the near future. The CDC has a very informative section on its website with many links to additional resources on vaccine development, the approval process, prioritization for distribution and safety factors https://www.cdc.gov/coronavirus/2019-ncov/vaccines/index.html. For those interested in specific details, I encourage reading this section and its related links.
Historically, the FAA has required one year after full FDA approval before considering allowing pilots to use a new product. Given the extraordinary circumstances of the pandemic, the FAA has announced a policy change allowing airmen who receive the Pfizer/BioNTech and the Moderna vaccines to return to flight duties after a 48 hour observation period and free from significant side effects. Due to production and distribution challenges along with vaccine prioritization guidance, I anticipate that most pilots will not have access to a COVID vaccine until the springtime. At that time, there may be several more vaccines that have received FDA EUA’s and may possibly be allowed by the FAA.
COVID Concerns for Medical Certification
Besides the lethality of the SARS-CoV-2 virus, particularly in high-risk sub-populations, other related medical issues are concerning. Persistent fatigue, respiratory compromise and a host of other symptoms such as loss of taste or sense of smell may persist following COVID – 19 infection.
More concerning are reports of neurological, cognitive and psychiatric symptoms after infection, even with less severe acute cases. The virus seems to affect the central nervous system in some victims. These effects may lead to additional medical certification screening requirements in those recovering from COVID, especially in more severe cases requiring medical support. This possibility has been discussed in the ICAO Medical Certification working group, but no countries have implemented additional requirements to date.
Pilots need to report all visits to healthcare providers in the last three years on their medical applications. Simple testing for COVID without a visit to a healthcare provider is not reportable. For pilots who have recovered from COVID, I recommend that they check with their AME prior to their next medical examination to see what documentation may be required to issue a medical certificate. I anticipate that most pilots will be able to have a medical certificate issued unless they required intensive care treatment. A clinical summary from a physician for those needing outpatient medical care and hospital records for those hospitalized overnight should be available for the AME.
The ICAO CAPSCA discussion and the Council’s Aviation Recovery Task Force have been working on strategies to allow international travel through a Public Health Corridor of clean airports, clean aircraft and clean aircrew/passengers. Currently, there are a variety of quarantine and testing requirements among various countries, or even regions within countries. This makes public health requirements very confusing and unpredictable for both passengers and crew. It is also a strong disincentive for passengers to travel and crews to accept trips if they risk unexpected mandatory quarantine and confinement. See CART new and updated Take Off Guidance Document.
Because of these problems, ICAO is looking to implement the Visible Digital Seal (VSD). The VSD would link secure, universally verifiable COVID test results and vaccination status (health documents) with passports, visa and emergency travel authorizations (travel documents) that could be read at both departure and at arrival countries. A traveler’s status and authorization to transit or enter a country, possibly without quarantine requirements, would be known prior to departure. As testing and vaccination capability improves, countries could amend their travel entry requirements based on a risk assessment in coordination with local public health authorities. Travel would be safer, more predictable and less likely to result in long quarantine periods or invasive testing upon arrival.
Recommendations for Aviation Professionals
The COVID pandemic will unfortunately be with us for a while. My advice to prevent infection and serious consequences of COVID-19 is to follow public health recommendations:
- Avoid exposure to known or potential COVID exposed/infected persons
- When avoidance is not possible, maintain social distancing indoors and outdoors
- Wear a mask of facial covering to protect others, and as evidence emerges, to shield yourself
- Wash your hands frequently with soap and water or use 60+% alcohol containing hand sanitizer
- If coughing or sneezing, use a disposable tissue or cough/sneeze in the crook of your elbow
- Avoid touching surfaces touched frequently by others [doorknobs, handles, handrails, counters, etc.]
- If infected or exposed, follow CDC guidelines for isolation or quarantine.
- Get a flu shot! It won’t protect against COVID, but will reduce the risk of flu and going to health care facilities where COVID may be present
- Take active steps to preserve your mental wellbeing – exercise outdoors, eat a healthy diet, practice some form of meditation/spirituality/mindfulness and reach out remotely to loved ones
- Maintain currency, training and flying skills if possible
- Be assured that traveling on an airplane is safer than being in public building gatherings or a commercial establishment, but staying home is probably the lowest risk
Be well and fly safely,