FDA Panel Endorses Pfizer Vaccine, 81,000 Doses Headed to Hawai‘i

Governor David Ige. PC: file Office of Gov. David Ige / Flickr

An estimated 81,000 doses of COVID-19 vaccine are headed to Hawai‘i’, with the first shipment of 4,875 doses of the newly FDA endorsed Pfizer vaccine to possibly arrive as early as next week, according to Governor David Ige.

Gov. Ige joined other state leaders in laying out the first steps of Hawai‘i’s COVID-19 vaccination effort.

Also today, Maui Health conducted a table-top exercise to practice and isolate any issues in the transport and storage of the COVID-19 vaccine, when it arrives in Maui County.

The first shipment is intended for priority groups in high risk settings including health care workers and long-term care facilities across the state. Both Gov. Ige and Lieutenant Governor Josh Green have said they will take the vaccine when they are able, and their place in line comes up.

State leaders say the FDA Vaccines and Related Biological Products Advisory found today that the vaccine is safe and effective and they will be considering emergency use authorization in the next day or so.  The emergency authorization is the process being used due to the rapid testing conducted to make a vaccine available in such a short period of time.

Lt. Gov. Green said he anticipates authorization approval in the next couple of days after today’s committee vote endorsing it as safe.

The Pfizer-BioNTech COVID-19 vaccine is described an MRNA COVID vaccination that requires two shots taken 21 days apart for full effectiveness.

Phase 3 clinical trials started in July of 2020.  “It’s been very well tolerated.  That’s very important because most of the adverse effects have been resolved almost immediately after,” said Lt. Gov. Green noting effects have included soreness in the arm and fatigue.

“They’ve tested it on may thousands of people and it’s working,” said Lt. Gov. Green.  “Is it effecatious enough?  The answer is yes.  In fact, many vaccines like flu vaccines are nowhere near effective as the Pfizer vaccine has been shown to be, which is 95 percent. If you only get one shot you won’t get full immunity, and that’s an important thing to recognize.  You really need to get both shots,” he said, noting that the vaccine is over 94 percent effective in adults over 65, who are considered higher risk for poor outcomes if infected with COVID-19.

“It’s been consistent across age, gender, race, ethnicity–all the demographics–which is important to us because we’re a very multi-ethnic culture,” said Lt. Gov. Green.

State officials say providers will not be able to begin to vaccinate groups in the first phase until the US Centers for Disease Control and Prevention Advisory Committee on Immunization Practices provides guidance on who can be vaccinated. ACIP guidance is expected in the coming days.

“This pandemic has cost Hawai‘i residents so much—the lives of loved ones, our health, and our economic security,” said Governor David Ige in a press release announcement. “The recommendation by the FDA panel to approve the Pfizer vaccine is a vital step in keeping our situation from becoming worse and beginning our road to recovery. Once final approval is granted, I am confident in the Department of Health’s ability to distribute vaccines across Hawai‘i.”

“Just hours ago, the FDA’s committee of experts voted overwhelmingly in favor to recommend Emergency Use Authorization of the Pfizer-BioNTech COVID-19 vaccine. We are optimistic that the FDA will grant the Emergency Use Authorization soon,” said Dr. Char, “However, we know that our work is just beginning. After months of planning, we are prepared to join with our partners to distribute the first shipments of a vaccine. As there will not be enough vaccine for everyone at first, we must first care for those who cared for us—essential healthcare workers and kupuna in long-term care facilities.”

Additional information provided by the state:

The first phase of Hawai‘i’s COVID-19 Vaccination Plan is divided into three groups:

• Phase 1a – Essential healthcare workers
• Phase 1b – Essential workers
• Phase 1c – 65 years and older and adults with high-risk medical conditions

Upon ACIP approval and guidance being issued on the Pfizer vaccine, Hawai‘i will move into Phase 1a. ACIP guidance could also lead to changes in prioritization. As new information and guidance becomes available, the state plan may be adjusted based on the national recommendations from ACIP, which is expected within a few days.

The Hawai‘i State Department of Health is working in close coordination with federal partners, the Hawai‘i National Guard, the Healthcare Association of Hawai‘i, and medical providers to accept and dispense the first shipments of COVID-19 vaccines.

Hawai‘i’s Phase 1a distribution focus will begin with high-risk health workers involved in direct patient care and workers who provide transportation, environmental services, and other healthcare facility services and who are at risk of exposure; and residents and staff of congregate long-term care facilities.

Following the vaccination of these groups, Phase 1b and 1c populations include first responders and essential workers, adults with high-risk medical conditions, and adults 65 or older.

The Moderna COVID-19 vaccine is scheduled to be evaluated by the federal Vaccines and Related Biological Products Advisory Committee on Dec. 17. If approval is granted, Hawai‘i is expected to receive 36,000 doses of the Moderna vaccine, in addition to nearly 46,000 doses of the Pfizer vaccine in the month of December alone.

Essential health care workers will be vaccinated at Points of Dispensing (PODs) across the state. Vaccinations will be administered to long-term care facilities through a federal partnership with Walgreens and CVS.

Both the Pfizer and Moderna vaccines require a two-dose regimen. The second dose must match the brand of the first dose. The second dose of the Pfizer vaccine needs to be administered not less than 21 days after the first dose, while the Moderna vaccine needs to be administered at least 28 days following the first dose. Following the administration of the first dose, the state will be able to order additional supply.

Additional vaccine supply is expected in the first half of 2021.