Americans with allergies can get Pfizer's Covid-19 shot if they don't have severe reactions to vaccines: FDA
About 1.6% of the US population has had a severe allergic reaction of some sort or another to food or some environmental aspect
People in the US can all receive Pfizer’s coronavirus vaccine unless they have experienced severe allergic reactions to a vaccine or one of the ingredients in this particular Covid-19 vaccine, according to the US Food and Drug Administration (FDA). The agency has advised people with allergies to consult with their doctors to make sure that they are not allergic to any of the components of the vaccine.
“If you’ve had a history of allergic reactions, obviously you should tell your doctor about those. But the vaccine is one that we are comfortable giving to patients who have had other allergic reactions besides those other than severe allergic reactions to a vaccine or one of its components. They (doctors) will help determine knowing what’s in the vaccine if you might be allergic to one of those components,” says Dr Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), the FDA division that authorized the vaccine.
He adds, “We may have to modify things as we move forward, but for right now we’re comfortable with this.” According to Dr Marks, about 1.6% of the population in the US has had a severe allergic reaction of some sort or another to food or some environmental aspect, and “we would really not like to have that many people not be able to receive the vaccine.”
The FDA will monitor side effects such as allergic reactions very closely via their safety surveillance systems in conjunction with the US Centers for Disease Control and Prevention (CDC). Sites, where Americans will be inoculated, will also have the ability to treat allergic reactions.
“We are making sure that sites, where this vaccine is being administered, have the ability to treat allergic reactions. I just want to assure the public that although there were these few reactions in Great Britain, these were not seen in the larger clinical trial data sets. We will be monitoring very closely for them, but we still need to learn more and that’s why we will be taking precautions,” he adds.
Two National Health Service (NHS) workers in the UK suffered serious allergic reactions shortly after receiving Pfizer’s vaccine. Both have recovered after treatment. However, the incidents prompted the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to announce that any person with a history of a significant allergic reaction to a vaccine, medicine, or food (such as previous history of anaphylactoid reaction, or those who have been advised to carry an adrenaline autoinjector) should not receive the Pfizer-BioNtech vaccine.
In the fact sheet for healthcare providers administering the vaccine, the FDA asks them not to administer Pfizer-BioNTech Covid-19 vaccine to individuals with a known history of a severe allergic reaction (such as anaphylaxis) to any component of the shot. “Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration” of the vaccine, it advises.
A presentation made to the CDC’s Advisory Committee on Immunization Practices (ACIP) on December 12 proposes that persons who have had a severe allergic reaction to any vaccine or injectable therapy (intramuscular, intravenous, or subcutaneous) should not receive the Pfizer-BioNTech vaccine at this time. “Vaccine providers should observe patients after vaccination to monitor for the occurrence of immediate adverse reactions: 30 minutes for persons with a history of anaphylaxis (severe allergic reaction), and 15 minutes for all other persons,” it notes.
However, Sarah Mbaeyi, a medical officer with the CDC’s National Center for Immunization and Respiratory Diseases, says that people that do report anaphylactic reactions to other vaccines or injectables “can still get the vaccine, but they should be counseled about the unknown risks of developing a severe allergic reaction and balance these risks against the benefit of vaccination.”
The CDC document titled clinical considerations for use of Pfizer-BioNTech Covid-19 vaccine, emphasizes that the vaccine may be administered to persons with underlying medical conditions who have no contraindications to vaccination. “Persons with HIV infection, other immunocompromising conditions, or who take immunosuppressive medications or therapies might be at increased risk for severe Covid-19. Data are not currently available to establish the safety and efficacy of the vaccine in these groups. These individuals may still receive Covid-19 vaccine unless otherwise contraindicated,” stipulates the guidance.
It calls for counseling people about the unknown vaccine safety and efficacy profiles in immunocompromised persons, the potential for reduced immune responses, and the need to continue to follow all current guidance to protect themselves against coronavirus.
As far as pregnant women are concerned, the CDC explains that there are no data on the safety of Covid-19 vaccines in this group. “If a woman is part of a group (for example, healthcare personnel) who is recommended to receive a Covid-19 vaccine and is pregnant, she may choose to be vaccinated. A discussion with her healthcare provider can help her make an informed decision,” recommends the agency.
It cautions that pregnant women could face an increased risk of severe illness (ICU admission, mechanical ventilation, death) and that there may be an increased risk of adverse pregnancy outcomes, such as preterm birth.
Experts say that considerations for vaccination among pregnant women should include the level of Covid-19 community transmission and risk of acquisition, her risk of contracting Covid-19 by occupation or other activities, the risks of the disease to her and potential risks to the fetus, vaccine efficacy, the known side effects of the vaccine, and the lack of data about the vaccine during pregnancy.
According to Dr Marks, for pregnant women and people who are immunocompromised, “it will be something that providers will need to consider on an individual basis.” He suggests that individuals consult with physicians to weigh the potential benefits and potential risks.
Since there is also no data on the safety of Covid-19 vaccines in lactating women or its effects on the breastfed infant or milk production/excretion, the CDC suggests that if a lactating woman is part of a group (such as healthcare personnel) who is recommended to get the shot, she may choose to get it. The Pfizer shot is an mRNA-based vaccine, which introduces mRNA to the human body, triggering human cells to produce the spike protein.
In response to these proteins, the body produces antibodies and other immune pathways are activated, guarding against infection. The CDC notes that “mRNA vaccines are not considered live virus vaccines and are not thought to be a risk to the breastfeeding infant.”