Pfizer’s Covid- 19 Vaccine causes a severe reaction in Two US Health care worker’s; FDA issues guidelines for people with a history of reactions

The world heaved a huge sign of relief and watched in awe when Britain and the US both gave the go-ahead for Pfizer and BioNtech Covid -19 vaccine and prepared for the vaccine to be rolled out to the first – listers.

However, in a second case registered after Britain, Washington reported severe side effects developed in two of the health workers after the vaccine was administered.

Two Alaskan health workers had a severe allergic reaction after taking the Pfizer and BioNtech Coronavirus vaccine.

According to the Bartlett Regional Hospital in Juneau, the two health workers had an adverse reaction 10 minutes subsequent to receiving the vaccine and were treated. One health worker has fully recovered, and the other is being kept under observation.

Of the two one Alaskan health workers, a middle-aged woman with no prior history of allergies complained of feeling flushed, rash over the face and torso, shortness of breath, and an elevated heartbeat; she was treated with epinephrine and other medications and the diagnosis according to the treating doctors was anaphylaxis, a severe allergic reaction. 

Her symptoms subsided but re-emerged when the doctors tried to stop her drip, and she was thus moved to the intensive care unit and kept under observation.

While the other health worker complained of eye puffiness, lightheadedness, and scratchy throat. 

Anaphylaxis – can be life-threatening, with weakened breathing and drops in blood pressure that usually occurs within minutes or even seconds after exposure to foods, or medicines, or other substances that the person may have an allergy against. 

Incidentally, reports of volunteers in Britain who were given the coronavirus Pfizer vaccine also had developed a severe reaction to the vaccine.

The volunteers who were administered the first trial shot developed Bell’s palsy, which causes temporary weakness or paralysis of the facial muscles. It happens when the nerves controlling the facial muscles become inflamed, swollen, or compressed. 

In this case, the FDA ( Food and Drug Administration) regulators had stated that it was unclear as to what caused Bell’s palsy in the four volunteers who received the first trail shots and had asked the health officials to monitor the condition of the volunteers and to watch out how many, and if other people too develop this side effect.

Apart from Pfizer and BioNtech, a second option is to be rolled out soon from Moderna Inc., and both the vaccines are based on the same type of technology and have similar ingredients. 

Both consist of genetic material called mRNA that is encased in a bubble of oily molecules called lipids. However, they use different combinations of lipids. 

The FDA insists that massive studies have been conducted on each vaccine, and no major safety concerns were reported.

What are the guidelines issued by US health authorities?

The US health authorities have warned doctors to watch out for rare allergic reactions to the people who have been administered the coronavirus Pfizer vaccines. 

Centers for Disease Control and Prevention have recommended that the vaccine be administered in settings with supplies, including oxygen and epinephrine, to manage the anaphylactic reactions. 

The CDCP has also issued guidelines that those who have been given the shot should stay in the facility for at least 15 minutes. Those with a history of allergies should wait for 30 minutes, so they can be treated immediately if they develop an allergy. 

FDA officials also have said that they would require Pfizer to increase its monitoring for anaphylaxis and submit data on it once the vaccine comes into further use. 

What happens when the Pfizer and Moderna Shots are given?

It is expected that either of the shots (Pfizer or Moderna), just like many vaccines, may cause some temporary discomfort. 

In addition to getting a sore arm, people can experience some other symptoms – fever, and flu-like symptoms – fatigue, aches, chills, headache and may last a day; these could be more common after the second dose is administered and in younger people.

These should be taken as signs that the immune system of the body is revving up, but it has been observed that the Covid -19 vaccines tend to cause more of such reactions than a flu shot, about what people may experience when they have received a shingles vaccination. But some symptoms are similar to covid -19 symptoms. 

What Do Pfizer and BoiNtech have to say?

Jerica Pitts, Pfizer spokesperson, said the company does not have all the Alaska situation details yet but was working with the local health authorities. 

She also mentioned that the vaccine comes with information warning that medical treatment should be available in rare anaphylactic events. The company will closely monitor all reports suggestive of serious allergic reactions following vaccination and update labeling language if needed. 

The authorities in Britain, after the workers developed a reaction to the vaccination, the authorities there had warned against giving the vaccines to anyone with a history of severe allergic reactions. 

The authorities later changed the and clarified their concerns – from “severe allergic reactions” to specify that anyone who has ever had an anaphylactic reaction to a food, medicine, or vaccine, the same should not be administered with the vaccine. However, they added that type of reaction to a vaccine is “very rare.”

What does it mean for these countries and the rest of the world?

According to reports, the US, Canada, and the UK, among some other countries, have secured enough Covid -19 vaccines for the entire population and in multiple doses. 

The roll-out of the Pfizer and BioNtech Covid -19 vaccines was seen with a sigh of relief even as new cases of the coronavirus infection are being reported all over the world.

To date, the total number of cases reported worldwide is over 69 million cases and 1.5 million casualties.

Massive amounts of money and efforts are on to not only find a vaccine, but also its administration to the respective populations of the countries will require huge amounts of money and consistent efforts.

Coupled with reported side effects – this could mean an additional sum of money and resources to be deployed to handle any such side effects amongst the vaccinated populations.

The task could be incredibly daunting for emerging countries with massive populations that are already facing economic recession, coupled with respective crises.

In India, that has already reported a technical recession, and its current crises in the financial sector particularly banks, no significant recovery in employment ratio, high inflation and currently also facing the farmers protest; to manage the population and start the inoculation drive in itself will be a considerable challenge both for the Modi Government and the concerned health authorities.

Add to this a not – so – state of the art health infrastructure and the additional deployment of resources both in terms of money and health resources to handle the side effects; it is a daunting task indeed.