COVID Vaccines Are Coming to the US – Now What?

Last week, media and social media accounts lit up with news of potential approvals of not one, but two COVID vaccines. Since the news broke, the United Kingdom’s Medicines & Healthcare Products Regulatory Agency approved emergency use of the Pfizer vaccine. Vaccinations began this week.

Canada issued interim approval of the Pfizer vaccine today. Health Canada hopes that initial doses will arrive in the country next week and vaccinations will occur within one or two days of the shipments’ arrival.

Vaccine Status in the United States

Pfizer and its partner BioNTech filed for FDA emergency use authorization (EUA) for their vaccine candidate, which was the first to report its positive findings. Moderna later followed with its own application. The FDA will hold meetings with the agency’s vaccine advisory committee tomorrow, Thursday, and an EUA for Pfizer could be issued as early as Friday.

According to the Washington Post, the meeting allows for members of the public to speak, “as a critical part of its effort to be transparent and convince people to take the vaccine.”

Once an EUA has been issued, Pfizer can begin supplying the country with vaccines. However, experts warn that this doesn’t mean that the vaccines will be suddenly available in all 50 states, to anyone who wishes to be vaccinated. While shipping can begin within 24 hours of approval, according to Operation Warp Speed, the number of available doses will be less than originally expected.

Who Will Have Access?

In May, Operation Warp Speed issued a statement declaring that there would 300 million doses of COVID-19 available by January 2021. However, news reports state that only 6.4 million doses will be available. It is important to note that the Pfizer product is a two-dose vaccine, which means that it takes two doses per person for immunity to COVID-19; 6.4 million doses would vaccinate 3.2 million people.

Given the slow rollout of this vaccine and others that will follow, not everyone who wants to be vaccinated will be able to at first.

The Centers for Disease Control and Prevention (CDC) has issued guidelines of proposed groups who should receive the vaccine in the early stages of the campaign.

The phase 1 group is itself split into two groups, 1a and 1b.

Phase 1a comprises healthcare personnel. This group includes about 21 million people who work in

• Hospitals
• Long-term care facilities
• Clinics
• Home healthcare
• Pharmacies
• Emergency medical services
• Public health

Phase 1b comprises essential workers, people with high-risk medical conditions, and adults who are 65 years or older.

Essential workers are those who work in:

• Food and agriculture
• Food services
• Transportation
• Education
• Energy
• Police services
• Fire services
• Manufacturing
• IT and communication
• Water and wastewater management

High-risk medical conditions include (but may not be limited to):

• Obesity
• Diabetes
• Chronic obstructive pulmonary disease (COPD)
• Heart disease
• Chronic kidney disease
• Cancer
• Organ transplants
• Sickle cell disease
• Smoking

People aged 65 years or older may be limited at first to those who live in:

• Skilled nursing facilities
• Assisted living facilities
• Residential care communities
• HUG senior housing

Plans Subject to Change

At this point, any guidance as to who will get the vaccines is subject to change. Much depends on the logistics of getting the vaccines to the locations and then organizing how to get the vaccines to the people or get the people to the vaccines.

The Pfizer vaccine may be the most challenging of all the vaccine candidates because it must be stored at minus 70 degrees Celsius, which is colder than it is during an Antarctic winter. This is only possible with special freezers that can keep at that temperature. Moderna’s vaccine can keep stable at minus 20 degrees Celsius, more in line with a standard freezer.

According to an NPR article published in November, Pfizer says it has packaging that can keep the vaccines cold enough with dry ice, allowing for storage for a few weeks if a freezer is not available. “I believe it can be done,” says Debra Kristensen, a 30-year veteran of vaccine innovation and supply chains at PATH, an international non-profit focused on public health. “Ebola vaccine, for example, was successfully used in a few African countries and also required this ultra-cold chain storage.”

While We Wait

The news regarding the vaccines is welcome, but the world is still a long way off from being safe from COVID-19. Even once anyone can get vaccinated, immunization will take time.

It can take a few to produce the antibodies that will protect people from the virus, and this will only occur after the second dose. So people can still contract the virus before the full immunization has taken effect. And, the two-dose vaccines will not work if people don’t return for the second dose. Therefore, it’s vital that people continue to follow infection prevention procedures, including wearing masks, keeping distance, and self-isolating when possible.

COVID-19 is a viral respiratory infection that can trigger viral sepsis. To learn more about COVID-19 and sepsis, visit the Sepsis Alliance COVID-19 Resource Page.