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With the COVID-19 pandemic hauling on and the United States seeing an alarming winter surge in cases, coronavirus vaccines offer us hope of regaining some semblance of everyday life next year.
At the beginning of this month, the Food and Drug Administration sanctioned its first emergency use authorization (EUA) for a vaccine against COVID-19 in people aged 16 years and older.
This EUA now permits the distribution of Pfizer-BioNTech’s new COVID-19 vaccine in the United States.
The FDA issued this authorization after examining the available efficacy and safety data on the new vaccine produced. Based on the evidence from ongoing clinical trials, the FDA found that the vaccine’s known and potential benefits outweigh the known and potential dangers.
The available data infers that after two doses, the vaccine is 95 percent effective at preventing COVID-19. Also, the research has found that the vaccine has a good safety profile.
Dr. Matthew Heinz, a hospitalist from Tucson, Arizona, said, “The close monitoring of a large number of participants during the study shows that the patient safety profile is excellent in terms of side effects.”
He said, “We have to proceed to monitor going forward and to continue collecting data to make sure it stays that way.”
After Receiving Pfizer’s Vaccine, 2 Alaska Health Workers Got Emergency Treatment
In a recent, two health care workers at the same hospital in Alaska developed concerning reactions barely minutes after getting Pfizer’s coronavirus vaccine this week, including one staff member who had to remain hospitalized until Dec. 17th.
According to the health officials, the cases would not impede their vaccine rollout plans and that they were sharing the information for the sake of transparency.
According to a hospital official, the first worker, a middle-aged woman who had no history of allergies, had an anaphylactic reaction that began 10 minutes after receiving the vaccine at Bartlett Regional Hospital in Juneau on Tuesday. She experienced a rash over her torso and face, shortness of breath, and an elevated heart rate.
Dr. Lindy Jones, the hospital’s emergency department medical director, said the worker received a shot of epinephrine, a standard treatment for severe allergic reactions. Her symptoms subsided but then re-emerged, after which we gave steroids and an epinephrine drip to her.
Her symptoms re-emerged yet again when doctors tried to stop the drip, so they shifted the woman to the intensive care unit, observed throughout the night, then removed off the cannula early Wednesday morning, Dr. Jones said.
The second worker was given his shot on Wednesday and experienced lightheadedness, eye puffiness, and a scratchy throat 10 minutes after receiving the injection, the hospital said in a statement. He was shifted to the emergency room and treated with epinephrine, Pepcid, and Benadryl. The worker regained normalcy within an hour, and the hospital discharged him.
The hospital has administered 144 total doses as of Dec. 16th night and said both workers did not want their experiences to negatively impact others lining up for the vaccine.
“We do not plan to change our vaccine schedule, regimen, or dosing,” Dr. Anne Zink, Alaska’s chief medical officer, said.
Although the Pfizer vaccine turned out to be safe and about 95 percent effective in a clinical trial involving 44,000 participants, the Alaska cases will likely intensify concerns about possible side effects. Experts said the developments might prompt tighter guidelines to ensure careful monitoring of the recipients for adverse reactions.
Dr. Paul A. Offit, part of an outside advisory panel and a vaccine specialist that recommended the FDA authorize the Pfizer vaccine for emergency use, said the researchers already took the appropriate precautions. For example, he said, the requirement that recipients remain in place for 15 minutes after getting the vaccine helped ensure the woman’s quick treatment.
“I don’t think this means we should stop vaccine distribution,” he said. But he said researchers need to find out “what component of the vaccine is causing this reaction.”
Dr. Jay Butler, a top contagious-disease expert with the Centers for Disease Control and Prevention, said the Alaska situation reflected that the monitoring system worked in the desired way. The agency has recommended administering the vaccine in settings with supplies, including oxygen and epinephrine, to manage severe allergic reactions.
Millions of Americans are in line to be immunized with the Pfizer vaccine by the end of the year. As of Dec. 16th night, it was unclear how many Americans so far have got the dose. Alex M. Azar II, the health and human services secretary, said his department would be releasing that data very soon.
The Alaska woman’s reaction resembled those of the two health workers’ anaphylactic reactions in Britain after receiving the Pfizer-BioNTech vaccine last week. Both of them recovered like her.
Pfizer’s trial did not observe any serious adverse events caused by the vaccine, although many participants experienced fevers, aches, and other side effects.
Pain around the injection area
The Pfizer-BioNTech COVID-19 vaccine is administered in two doses, three weeks apart.
The doctors have collected the vaccine’s safety data from 37,586 participants enrolled in an ongoing phase 3 clinical trial.
Among those participants, 18,801 have received the vaccine, and 18,785 have received a placebo. The researchers observed them for a median of 2 months following vaccination.
The most commonly reported side effect of the vaccine is an injection site reaction. Such reactions can cause some pain and other symptoms around the area of the vaccine injection.
“You sometimes get some redness, some warmth, a little bit of mild swelling or firmness around the site of the injection. That’s very typical,” Heinz told Healthline.
“It can be a little tender; it can hurt to move the arm a little bit,” he continued.
Eighty-four percent of participants who received the vaccine reported reactions in the injection site.
Muscle pain, fatigue, headache
Additionally, commonly reported side effects of the Pfizer-BioNTech COVID-19 vaccine include fatigue, headache, and muscle pain.
The trials show that roughly 63 percent of research subjects who received the vaccine reported fatigue, while muscle pain and headache have affected about 38 and 55 percent of participants, respectively. Mostly, those symptoms have been mild and resolved within a few days.
Few numbers of participants reported fever, chills, or joint pain, following vaccination.
The trial participants were more likely to experience such symptoms following the vaccine’s second dose.
“The reaction to the second dose turns out to be a little more of an intense response,” Heinz said.
He added, “It gets hit with another dose of the vaccine, and it has a sort of quicker and more robust response. That makes a lot of sense immunologically.”
Rare-serious adverse effects
The participants who received the vaccine and those who got the placebo reported less than a 0.5 percent rate of serious adverse events, with no significant differences between the two groups involved.
Only four participants developed Bell’s palsy who received the vaccine, while those who got the placebo reported none.
Nevertheless, those four cases are consistent with the rate of Bell’s palsy in the general population. Meanwhile, there’s no clear evidence that the vaccine caused Bell’s palsy.
Severe allergic reactions to vaccines are infrequent, but they can happen. The FDA recommends that people who have experienced a severe allergic reaction to a previous dose of the Pfizer-BioNTech COVID-19 vaccine or any of its ingredients should not receive it.
Handling common side effects
Dr. Heinz suggested that people might want to schedule their vaccinations at a time when it’s easier to manage potential side effects such as fatigue or headache.
If you develop pain around the injection site, you can treat it with over-the-counter medication. Such medications may also help relieve joint pain, fever, headache, or muscle pain.
“You only need a couple of Advil and a dose of Tylenol to help with discomfort and swelling,” Heinz said.
In case of side effects that are bothersome or do not resolve, contact your healthcare provider. Call 911 or go to the emergency room if you think you might be having a severe allergic reaction.
Contemplating the benefits and risks
It’s essential to recognize that some side effects of the Pfizer-BioNTech COVID-19 vaccine are common and expected. On experiencing mild to moderate side effects after the first dose, you should not skip the second dose.
“After only one dose, your immunity is incomplete, and it might not respond in the desired way. Dr. Waleed Javaid, an associate professor of contagious disease at Icahn School of Medicine at Mount Sinai in New York City, said, “You will likely waste the first dose if you don’t get the second one in time.”
Speak out your questions or concerns about the vaccine with your healthcare provider, Javaid recommends.
He noted that it’s essential to consider the potential benefits and the potential risks of the vaccine.
“Injection site reactions, some aches, and pains, some other potential side effects — versus death. That’s the balance people have to think about,” he said.