Pfizer Covid-19 vaccine candidates in US report allergic reaction, as UK agency puts out advisory

India’s regulatory agency has put SII and Bharat Biotech candidates’ clearance on hold as the expert committee requests more data from firms
Pfizer Covid-19 vaccine candidates in US report allergic reaction, as UK agency puts out advisory

Barely a week has passed since the UK government had announced the emergency authorisation of Pfizer/BioNTech Covid-19 vaccine, and the first candidates have already been administered the vaccine. The company has already gained emergency use authorisation from Canada and Bahrain as well. However, a few candidates in the United States have reported feeling adverse effects from the Pfizer vaccine.

The UK’s Medicines and Healthcare Products Regulatory Agency has issued a new advisory saying, “Any person with a significant allergic reaction to a vaccine, medicine, or food (such as the previous history of anaphylactic reaction or those who have been advised to carry an adrenaline auto-injector) should not receive the Pfizer BioNTech vaccine.” The agency added that resuscitation facilities should only be carried out in facilities where resuscitation measures are available.

Four people among the Pfizer candidates’ test candidates reported adverse effects, mainly a condition called Bell’s palsy. The latter is a temporary weakness or paralysis of the muscles in the face, causing either drooping or stiffness. However, the authorities are yet to determine if the adverse effects are a direct result of the vaccine. The Food and Drug Administration will permit the usage of the vaccine only after properly examining all test data and making sure that there are no red flags.

Meanwhile, Pfizer’s candidate joins the Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin in seeking the Central Drugs Standards Control Organisation’s permission for emergency use authorisation. According to the minutes of the Drug Control General of India’s expert committee, Pfizer “has requested more time for making presentations before the committee.” Meanwhile, SII and Bharat Biotech candidates’ condition seems to be on hold as the committee has asked the duo for more data. From Biotech, the committee recommended the presentation of “safety and efficacy data from the ongoing Phase III clinical trial in the country for further consideration.”

The case is not simple for SII, as the committee’s recommendation is a long list. The recommendations include, “Updated safety data of phase II/III clinical trial in the country; Immunogenicity data from the clinical trial in the UK and India; and the outcome of the assessment of UK-MHRA for grant of EUA.”

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