As of Labor Day weekend, it appeared the oft-discussed “new normal” in the United States includes COVID-19 vaccine mandates in many components of federal and state governments as well as private business.
Though far from universal, the requirements became more prevalent after the U.S. Food and Drug Administration (FDA) on Aug. 23 approved the Pfizer-BioNTech vaccine. FDA approval of the Moderna and Johnson & Johnson vaccines, respectively, is expected in the very near future.
Two days after the Pfizer approval, Secretary of Defense Lloyd J. Austin III issued a memorandum for “Mandatory Coronavirus Disease 2019 Vaccination of Department of Defense Service Members.” The memo directs the secretaries of the military departments to immediately begin full vaccination of all members of the armed forces under DOD authority on active duty or in the reserve, including the National Guard, who are not fully vaccinated against COVID-19. Many high-profile businesses also are requiring vaccines, as are some sports and concert venues. As previously reported, the SIU and the American Maritime Association, in accordance with a recently announced arbitration decision, signed a memorandum of understanding (MOU) for implementing a COVID-19 vaccine mandate, effective Oct. 1, 2021. Based on the arbitration results, the union subsequently agreed to the same requirements with its non-AMA companies in the deep-sea sector.
The MOU spells out the following for vessels covered under the SIU standard freightship and tanker agreements. (Again, the same rules apply to mariners sailing on other deep-sea vessels as well.)
- All crew joining a vessel, regardless of job status, (permanent, trip tour, rotary, or trip relief), on and after Oct. 1, 2021 must provide proof of a COVID-19 vaccine.
- The following vaccines are acceptable: Pfizer – both shots – second shot prior to joining; Moderna – both shots – second shot prior to joining; Johnson & Johnson – 1 shot – 2 weeks prior to joining.
- Non-vaccinated crew on vessels, as of Oct. 1, 2021, will be allowed to finish their current tours. However, should the Company make arrangements for them to be vaccinated in a U.S. port after Oct. 1, 2021 and they refuse, the Company will call for their relief and when their replacement reports aboard, their employment will end.
- In the event of an emergency situation the Company and Union may agree to allow unvaccinated mariners to join a vessel, however all reasonable efforts will then be made to secure a vaccine for such mariners as soon as possible. Any such mariners will need to observe all of the COVID-19 safety protocols that have been in place during this pandemic, to include but not be limited to, testing, social distancing, restriction of movement on the vessel, restriction to ship in port without payment of penalties, etc.
- Union representatives will try to assist crew members in locating vaccine sites and scheduling appointments if requested.
- The requirements set forth above for new crew joining a vessel on or after Oct. 1, 2021 apply as well to permanent crew returning to vessels.
- Medical Exemptions: The Medical Director of the Seafarers Health and Benefits Plan will work with the parties to develop medical exemption protocols.
- Religious Exemptions: Religious exemption requests will be determined on a case-by-case basis. Factors to be considered include prior religious objection to receiving other required vaccines.
- If any individual Association Company bargains with any other shipboard union and should agree to less stringent protocols and/or requirements or the payment of any compensation or bonus for agreeing to and subjecting oneself to a COVID-19 vaccine, the same shall be offered to crewmembers represented by the SIU on its ships. Any such agreement shall not be applicable to other Association companies.
- To assist in the implementation of these conditions, fully vaccinated Union representatives will be allowed to board vessels to have discussions with the vessels’ crews. Any such Union representatives will abide by all COVID-19 protocols.
- All Association Companies will make reasonable efforts to try to have any vendors or other individuals who board any covered vessel fully vaccinated before boarding any such vessel. Both parties acknowledge that the Association’s companies do not control vendors or their employees.
Also as of Oct. 1, anyone entering a Seafarers hiring hall must provide either proof of being fully vaccinated against COVID- 19; or a completed, signed exemption form along with a negative test result from within the last 48 hours. This policy was adopted by the trustees of the Seafarers Joint Employment Fund (hiring halls).
Seafarers are encouraged to bring their respective vaccination cards to the halls as soon as possible so those documents may be scanned into the SMIS database.
Other safety precautions remain in place at all of the halls, including requirements to wear masks and socially distance. Proper sanitation is always encouraged.
Similar vaccine mandates take effect at the headquarters building and at the Paul Hall Center in Piney Point, Maryland, beginning Oct. 1. (Members are encouraged to contact their respective port agents with any questions.)
According to the FDA, the Pfizer vaccine now will be marketed as Comirnaty (koemir’- na-tee), and it is approved “for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
Acting FDA Commissioner Janet Woodcock, M.D., stated, “The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product. While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval. Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”
Austin wrote in his memo, “To defend this Nation, we need a healthy and ready force. After careful consultation with medical experts and military leadership, and with the support of the President, I have determined that mandatory vaccination against coronavirus disease 2019 (COVID- 19) is necessary to protect the Force and defend the American people. Mandatory vaccinations are familiar to all of our Service members, and mission-critical inoculation is almost as old as the U.S. military itself. Our administration of safe, effective COVID-19 vaccines has produced admirable results to date, and I know the Department of Defense will come together to finish the job, with urgency, professionalism, and compassion.”