Hawaii’s average COVID- 19 case counts are still declining as updated boosters took a step closer to availability.
On Wednesday, the U.S. Food and Drug Administration authorized its first update to COVID-19 vaccines —newly formulated bivalent vaccines that also target omicron subvariants BA.4 and BA.5. These “updated boosters” by Pfizer-BioNtech and Moderna, pending approval by the Centers for Disease Control and Prevention, could be available within days.
The CDC’s advisory panel is expected to meet today to discuss the updated boosters, as well as how they would be administered.
“Although the current COVID-19 surge is winding (down) overall, it’s predicated that we’ll enter again another surge as we spend more time indoors later this fall and winter,” said FDA commissioner Dr. Robert Califf during a virtual news conference Wednesday. “We also know that staying up to date on vaccines is the best way to protect yourself from COVID-19 and its most devastating consequences, and as the virus has evolved, the original vaccine is not as protective against the currently circulating strains as it was against the original virus.”
With that in mind, Califf said the FDA has been planning updated boosters since earlier this year in an effort to “be a step ahead” of an oncoming wave.
The Hawaii Department of Health has ordered nearly 38,000 doses of the bivalent vaccines, which contain two messenger RNA components — one from the original strain of the coronavirus and the other one common in subvariants BA.4 and BA.5.
The DOH has ordered more than 27,000 doses of the Pfizer and more than 10,000 of the Moderna bivalent vaccines. DOH said more can be ordered in following weeks.
The updated Pfizer booster is expected to be available to individuals ages 12 and up, and the Moderna booster to those ages 18 and up, at least two months following the primary series of vaccines or most recent booster dose.
At the same time, the FDA said the original vaccines are no longer authorized as boosters for those ages 12 and up. The FDA said this is so adolescents and adults covered by this new authorization are able to get the most up-to-date version of a booster vaccine. DOH said people in that large age bracket with a scheduled booster shot should reschedule an appointment for the bivalent boosters once scheduling opportunities open up.
Those who have not been vaccinated against COVID-19 yet would continue to receive the monovalent vaccines for their primary series.
COVID trends down
The DOH on Wednesday reported the state’s seven-day average of new cases fell to 245 — down from 322 reported Aug. 24, adding to a continual decline. Actual numbers are estimated to be at least five to six times higher since these do not include home test kit results.
Also, the state’s average positivity rate continued its downward trend to 7.3% compared with 8.6% reported the previous week, marking the fifth consecutive week of declines since July 27 — a considerable drop from early June, when the state’s average positivity rate had peaked to 19.2%.
Hospitalizations of patients with COVID-19 are also dropping. For the past week, the Healthcare Association of Hawaii reported an average of 102 COVID-19 patients hospitalized per day, down from 119 the previous week, and an average of 21 new COVID-19 admissions per day.
The DOH reported 12 more deaths, bringing the state’s coronavirus-related death toll to 1,644.
Omicron subvariant BA.5 has been the predominant strain in the U.S. and Hawaii for several weeks now.
In Hawaii, BA.5 made up 91% while BA.4 made up 4% of variants circulating for the two-week period ending Aug. 13, according to a report released Wednesday. A new variant of concern, BA.4.6, made up 3% of variants in the state.
Also, one case of BA.2.75, an omicron subvariant nicknamed “centaurus,” has been detected on Maui. Epidemiologists are keeping an eye on the subvariant because it has outcompeted BA.5 to become dominant in India.
Bivalent vaccines
Health officials are hoping that the availability of the new bivalent vaccines will spur more people to get boosted as the pandemic stretches on.
Nationally, about 48.5% of Americans have received a COVID-19 booster shot. In Hawaii, 77.3% of the state population as of Wednesday had completed the primary series, with about 45% boosted once, and 11.6% boosted twice.
Dr. Peter Marks, FDA vaccine chief, said the agency looked at the “totality of evidence” in making the decision to authorize the updated boosters. With hundreds of millions of mRNA vaccine doses administered nationally, the FDA believes the original COVID-19 vaccines are very safe, he said.
The mRNA in these vaccines is, according to the FDA, a specific piece of genetic material that instructs cells in the body to make the distinctive spike protein of the original virus strain as well as of BA.4 and BA.5.
The FDA team looked at data from a clinical trial for a vaccine containing an mRNA component for BA.1, which offers an idea of how the bivalent vaccines might behave for BA.4 and BA.5. It also analyzed data from nonclinical studies in animals that found the new vaccines evoke an immune response in the same way as previous ones, he said.
“Based on the data, the updated boosters are expected to provide increased protection against the currently circulating omicron variant,” Marks said. “Additionally, side effects of the boosters are expected to be similar to those commonly reported for mRNA monovalent vaccines.”
Some critics have expressed concerns over the authorization of the new vaccines without results — such as data on BA.5 variant-specific neutralizing antibodies — from human trials.
But Marks said influenza vaccines are often updated annually for strain changes without clinical data, also based on the “totality of available evidence.”
He said ongoing studies will be carried out to determine the specific robustness of protection offered by the bivalent boosters.
“We’re very confident in the data used to support today’s actions particularly as we seek to stem the current wave of COVID-19,” he said Wednesday, “and hopefully stave off the coming wave of COVID-19 predicted by scientific models.”
BIVALENT COVID-19 BOOSTERS AUTHORIZATION
>> Pfizer: Ages 12 and older at least two months after completing primary vaccination or the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.
>> Moderna: Ages 18 and older at least two months after completing primary vaccination or the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.
Source: FDA
