On Thursday afternoon, an FDA advisory panel voted to recommend an emergency use authorization for the COVID-19 vaccine produced by Pfizer and BioNTech. The recommendation means the FDA could issue the authorization within days, or sooner, paving the way for Louisiana hospitals to begin vaccinating frontline workers as soon as Monday.
Louisiana expects to receive 39,000 total doses of the vaccine in the first shipment from the federal government, which is expected this weekend or early next week. According to Louisiana Department of Health spokesperson Kevin Litten, the largest hospital systems will receive shipments directly, while LDH will receive a separate shipment that it will subdivide and distribute.
In a press conference Thursday afternoon, Gov. John Bel Edwards said that the vaccine would be shipped within hours of FDA approval, although it has to wait for a final recommendation from the CDC’s Advisory Committee on Immunization Practices to begin using the vaccines. The committee has meetings scheduled on both Friday and Sunday.
Earlier this week at a White House vaccine panel, Edwards said that all vaccines would be administered within 48 hours of arriving in Louisiana. The vaccine is given in two doses, three weeks apart, and Edwards said that the state will rely on follow up shipments for the second shots, rather than holding them in reserve.
Edwards also stated that the state will receive about 40,000 doses in the week following the first shipment.
The New Orleans VA Health Care System will also receive doses independently of the state shipment.
Litten said that LDH didn’t have precise numbers on how many vaccines will be allocated to New Orleans, because the federal government is communicating directly with hospital systems about the size of those shipments.
Louisiana will receive approximately 1.35 percent of the first shipment of vaccines, which is roughly equal to the state’s percent of the US population. (The federal government is holding half of the first 6.4 million doses in reserve to distribute for follow-up doses.)
In a press conference with Edwards last week, Admiral Brett Giroir, the assistant secretary for Health and Human Services, and the White House testing czar, said that he anticipates roughly 3.5 million vaccines will be manufactured each week going forward.
According to an application filed to the FDA, Pfizer’s vaccine is 95 percent effective at preventing severe COVID-19 a week after the second dose. The vaccine must be administered in two doses 21 days apart, and the state plans to use its existing immunization tracking system, LINKS, to notify people when they need the follow-up shot.
So far, Pfizer has not provided any data showing that the vaccine prevents transmission — those who receive it may only be protected from severe illness, and could still be able to catch and spread the virus.
That uncertainty has huge implications for the vaccine’s effect on the surge that threatens to overwhelm Louisiana’s hospital system.
“In terms of stopping the epidemic, [this vaccine] is going to have minimal impact until it gets to a substantial proportion of the population,” said Susan Hassig, an infectious disease epidemiologist at Tulane who serves on the state’s vaccination task force.
Still, she said, even a vaccine that doesn’t stop transmission will help reduce the burden on hospitals if it keeps healthcare providers healthy and reduces illness in high-risk settings like nursing homes. “If it keeps them from being hospitalized, that’s a substantial benefit.”
Based on recommendations from the CDC panel and Louisiana’s vaccine planning task force, the first phase of immunizations will go to healthcare workers who are in direct contact with COVID patients, and those working in long term care facilities. The state estimates that there are between 190,000 and 215,000 people in Louisiana across those two categories, 125,000 to 135,000 of whom are frontline healthcare workers.
Litten said that non-medical hospital staff who work in COVID wards, like cleaning and maintenance staff, are included in the group.
This first shipment of immunizations will go exclusively to healthcare workers.
“Long term care will probably happen in the next shipment,” said Litten.
That’s in part because the Pfizer vaccine needs to be stored at roughly negative 94 degrees Fahrenheit, which requires specialized ultra-cold freezers. Most of those freezers exist in large hospitals, although the state has ordered several of its own for vaccine distribution.
At a press conference Thursday afternoon, Edwards said that a separate vaccine developed by Moderna, which has less stringent temperature requirements, would go to long term care facilities. The federal government has contracted Walgreens and CVS to distribute those vaccines, and Edwards said that all long term care facilities in Louisiana had decided to use the pharmacies.
The Moderna vaccine has also hit its benchmarks in Phase III trials, and is in the process of applying for an EUA as well. It is expected to be approved in mid-December.
At the press conference, Dr. Joseph Kanter, the interim Assistant Secretary for the Louisiana Office of Public Health, said that if Moderna’s approval process goes according to schedule, Louisiana will receive about 80,000 doses by Dec. 27.
But the recommendations leave a lot of leeway in deciding who should be prioritized within each shipment. Right now, individual hospital systems are responsible for deciding which of their frontline staff will actually receive the first dose.
Ochsner Health is holding a press conference tomorrow at noon to discuss the details of its vaccination plans.
A spokesperson for LCMC Health, which manages several hospitals in the New Orleans area, including the University Medical Center, said that the system “is not sure of our numbers. That is a question for LDH to answer. Our front-line teams who work in the emergency departments and on COVID units are priority. We’ll share more when the time is appropriate.”
LDH anticipates that the guidance coming to ACIP before vaccines actually arrive in the state, which may clarify those decisions. It will also likely issue guidance on the use of the vaccine in different age groups, pregnant people, and how to interpret the reports of allergic reactions among recipients in the United Kingdom, Hassig said.
The next doses
The state is also waiting on guidance from the CDC’s ACIP on how to finalize the next phases of immunizations. So far, its plans have aligned with the recommendations of ACIP.
The state’s vaccination playbook recommends that the second phase of vaccines be distributed to a wide range of essential workers and people at risk of extreme illness.
Essential worker categories include all hospital and urgent care personnel, firefighters who respond to medical calls, EMTs, law enforcement, home healthcare workers, and public transit employees. Officials within GOHSEP and LDH who are “serving an emergency support function” are also prioritized. Correctional facility employees are also included in this category.
High risk categories include residents of congregate long term care facilities and people over 65 with conditions that put them at high risk for severe COVID, like sickle cell, obesity, heart disease, and Type 2 diabetes.
Only in the following phase would people incarcerated in jails and prisons receive vaccines, along with grocery store employees, utility personnel, postal workers, childcare providers, K-12 educators, and people between 18 and 64 with preexisting conditions that put them at high risk for complications from the disease.
The state Department of Corrections says that 31 people have died of COVID while incarcerated in state prisons. There is currently no comprehensive data on how many people have died in jails, but Orleans Parish’s jail experienced a massive outbreak in the spring, and over the summer, one man died while positive for COVID. Much like nursing homes, incarcerated adults have higher rates of preexisting conditions and live in congregate settings that foster large outbreaks.
“There were many of us in the vaccine prioritization group that argued for having them up considerably higher,” said Hassig. “The unfortunate reality for the state prison system is that most of those people have already been infected. There’s certainly a real recognition of the need to provide them with the vaccination, but that would be my estimate about why they were placed where they were on the list.”
Those incarcerated by the federal government, including ICE detainees in the state, will not receive vaccines through the state plan.
In the final phase, anyone in the state could receive a vaccine, although ACIP may recommend that some (including children and pregnant people) not take it for safety reasons.
However, at last week’s press conference, Giroir made clear that those decisions could be reevaluated based on federal recommendations.
“Once you get to the next level, there’s going to be a lot of controversy. It depends on what you’re trying to do. There are good arguments for essential workers and first responders, but if your hospitals are almost full or overwhelmed, there would be a larger argument for immunizing those who would be in the hospitals, like the non-nursing home elderly.”