Pago Pago, AMERICAN SAMOA — Individuals who are not eligible for the COVID-19 vaccine including a “special consideration” group of the population, such as pregnant women, were among other issues that surfaced during a news conference earlier this week where health officials shared local preparations and plans to receive and distribute the vaccine, which arrives tomorrow.

Among concerns that have surfaced since the US Federal Food and Drug Administration (FDA) gave approval for the Pfizer vaccine are the side effects and who is not eligible to take this new vaccine. 

According to the federal government, more than 40,000 people participated in the Pfizer vaccine trial before the FDA approval.

DoH Pharmacist, Dr. Francine Amoa — who is a member of the government’s COVID-19 Vaccine Distribution Task Force and chair’s the panel’s distribution working group explained during the news conference that the “emergency use authorization” issued last Friday by the FDA, outlines those individuals who are eligible and considered not eligible for the vaccine.

“So the only individuals that came out clearly [as] not eligible — again based on those who participated in the trial — is anyone who is younger than 16,” she said, and noted that these individuals “cannot get the vaccine because there’s no safety data in this population group.”

According to the FDA, 16 years and older can take the vaccine.

Dr. Amoa said the second group not eligible for the vaccine is someone who has a history of severe allergic reaction to an injectable medication. Anyone who’s had a severe allergic reaction to a previous vaccine that they had.”

“So those with food allergies — that group is okay — as long as you didn’t develop a severe allergic reaction to injectable medicine,” she pointed out.

A DoH information sheet shared with the media states that “signs of a severe allergic reaction” can include difficulty breathing; swelling of face and throat; a fast heartbeat; a bad rash all over your body; and dizziness and weakness.”

Another group, is called “special considerations due to lack of safety data” — and they are “pregnant women” and “immune-compromised individuals.”

“They’re not saying, they’re not eligible, but are saying, you may want to have a conversation with your doctor before you get the vaccine,” she said, and “we’re talking specifically, pregnant women because there is no safety data for pregnant women.”

“For pregnant women, who may work in the hospital, and are health care workers, they need to talk with their provider or doctor before they get the vaccine. They were not included in the vaccine trial,” she said, and agreed with news reporters that there is a large population of pregnant women in the territory.

According to the DoH and LBJ vaccination plan, healthcare workers and first responders are priority to get vaccinated.

The other group with “special consideration” is “immune-compromised individuals”. For example, said Dr. Amoa, are patients who are in chemotherapy, HIV patients as there is no safety or advocacy data, meaning they were not part of the vaccine trial.

So the manufacturer and the FDA are saying, “we really don’t know how these individuals would respond to the vaccine if they get it,” she said.

DoH also shared information on side-effects from the Pfizer vaccine, with Dr. Amoa saying DoH has been informed that the side effects are “short term” and “it should go away in a day or two.”

According to FDA, the most commonly reported side effects, of the vaccine, which typically lasts several days, are pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever.

“Of note, more people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose,” said FDA (www.fda.gov) in a brief summary of information about the vaccine.

At the news conference, Dr. Amoa said, “We are going to ask all those who take the vaccine to report back to us any individual who develops any side effects of any severity.”

“W are required as vaccine providers to report this back to the FDA and CDC because they are still monitoring this vaccine,” she pointed out.

DOH — which has launched a mass media campaign on the vaccine — asked the public to contact their hotline — 219 — for any seeking more information on this vaccine.