With the UK being the first country to start distributing and administering the Pfizer/BioNTech Covid-19 vaccine, the rest of the world is holding its breath to see if everything goes smoothly. And for the most part, things seem to be fine.
The one notable exception is that two NHS healthcare workers exhibited severe allergic reactions from the vaccine. Both of them experienced symptoms of an anaphylactoid reaction and were administered in a hospital on Tuesday, December 8th. After receiving the appropriate treatment, both recovered within a day.
While unfortunate, this episode is not entirely surprising – both NHS workers had a history of allergic reactions to both foods and medicines to the point of carrying adrenaline auto-injectors with them.
What does this mean for us?
The good news is that the Pfizer/BioNTech Covid-10 vaccine is still considered safe for use. The only asterix is that people with a history of severe allergic reactions to medicine should avoid taking the vaccine for now. The UK Medicines and Healthcare products Regulatory Agency (MHRA) told NHS trusts to adhere to this new guideline and to continue administering the vaccine.
The national medical director of the NHS, Professor Stephen Powis explained the situation clearly:
“As is common with new vaccines, the MHRA have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination after two people with a history of significant allergic reactions responded adversely yesterday. Both are recovering well.”
Dr. June Raine, chief executive at MHRA said in front of a committee of British MPs that while the allergic reactions “were not a feature” of the vaccine that was expected, the necessary precautions for monitoring for side effects were taken.
“The role is before, during and after, and there is a true end-to-end looking from the scientific laboratory bench through to the patient who yesterday first received the vaccine,” Dr. Raine said in front of the Commons Science and Technology Committee.
“As an illustration to this, I may share with the committee that even last evening we were looking at two case reports of an allergic reaction.
“We know from the very extensive clinical trials that this wasn’t a feature but if we need to strengthen our advice now that we have had this experience in the vulnerable populations … we will get that advice to the field immediately.”
A spokeswoman of Pfizer also addressed the issue by saying “We have been advised by MHRA of two yellow card reports that may be associated with allergic reaction due to administration of the Covid-19 BNT162b2 vaccine.”
“As a precautionary measure, the MHRA has issued temporary guidance to the NHS while it conducts an investigation in order to fully understand each case and its causes. Pfizer and BioNTech are supporting the MHRA in the investigation.”
“In the pivotal phase three clinical trial, this vaccine was generally well tolerated with no serious safety concerns reported by the independent Data Monitoring Committee. The trial has enrolled over 44,000 participants to date, over 42,000 of whom have received a second vaccination.”
The “yellow card” scheme being the UK’s system for gathering and monitoring information regarding concerns related to medicines and medical devices.
The official advice of the MHRA states: “Any person with a history of a significant allergic reaction to a vaccine, medicine or food (such as a previous history of anaphylactoid reaction or those who have been advised to carry an adrenaline auto-injector) should not receive the Pfizer/BioNtech vaccine.
“Resuscitation facilities should be available at all times for all vaccinations. Vaccination should only be carried out in facilities where resuscitation measures are available.”
In short, while there were a couple of issues with the vaccine, the UK health officials were not caught off-guard and everything is under control.
Professor Chris Whitty, chief medical officer for England said that the NHS and the MHRA are in a “very good position” to deal with any other possible issue although no new problems are expected. He said that “inevitably you accrue more information over time”, acknowledging the fact that with such a rushed vaccine, it was all but inevitable that there are going to be some minor issues at first.
“The NHS through the MHRA is in a very good position to make sure that we can pick things up quickly, identifying them, communicate them widely, ensure that we improve practice”, he added.
Dr. Raine said that US health regulators are close to finalizing their review of the vaccine as well.
“It is my understanding that the Food and Drug Administration will be looking this week to conclude their review, and the European Medicines Agency fairly shortly thereafter,” she said.
Should you take the vaccine when it becomes available to you?
So far, all health officials responsible for reviewing, handling, distributing, and administering the Pfizer/BioNTech Covid-19 vaccine say that the vaccine is safe for use by people with no history of medical allergic reactions.
How do I know if I have drug-related allergies?
The best thing you can do before getting the Pfizer/BioNTech or any other Covid-19 is to consult with your physician about your allergies. If you have no record of drug-related allergies yet, your doctor can perform some quick and easy tests to determine whether you have any allergies and what they might be.
The most common drug allergies are:
- Antibiotics, such as penicillin
- Anti-seizure drugs
- Anti-inflammatory drugs, like ibuprofen and naproxen
- HIV drugs
- Monoclonal antibody therapy
- Sulfa drugs
If you know that you’re not allergic to any of those, you are most likely in the safe group. Still, it’s smart to lean on the safe side and consult with your physician. Aside from that minor precaution, however, there doesn’t seem to be any reason to skip the Covid-19 vaccine so far.
Even just in the few first days of administering the Covid-19 vaccine, thousands of people have already taken it with no unexpected side effects. UK Health Secretary Matt Hancock called the first day of vaccination “V-Day” and so far the process is going well.
Still, Mr. Hancock reminded people that several thousand vaccinations are not the end of the pandemic and we should “temper our joy and enthusiasm” because it’s still going to be months before things start decisively changing for the better.
He added: “Let’s not blow it since we can see the answer is on the horizon.” Nevertheless, the almost issue-free success of the vaccine so far is good news. Both healthcare personnel and elderly people are taking the vaccine well, including the very first person to take the vaccine – 90-year-old Margaret Keenan who said she felt “so privileged” to make history as the first person to be vaccinated with a Covid-19 vaccine.