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Possible allergic reactions to Moderna COVID-19 vaccine under probe

The confirmation comes after California State Epidemiologist Dr Erica Pan on Sunday recommended halting the administration of lot 41L20A of the Moderna COVID-19 vaccine due to possible allergic reactions that are under investigation.

January 20, 2021 / 06:53 PM IST
Source: Reuters

Source: Reuters

US-based drugmaker Moderna has confirmed that it has received a report from California's health department that several individuals at one vaccination centre in San Diego were treated for possible allergic reactions after vaccination from one lot of the company's COVID-19 vaccine.

The company is "fully cooperating" with the California Department of Public Health (CDPH) in investigating these reported adverse events, Moderna said on Tuesday.

The confirmation comes after California State Epidemiologist Dr Erica Pan on Sunday recommended halting the administration of lot 41L20A of the Moderna COVID-19 vaccine due to possible allergic reactions that are under investigation.

"A higher-than-usual number of possible allergic reactions were reported with a specific lot of Moderna vaccine administered at one community vaccination clinic. Fewer than 10 individuals required medical attention over the span of 24 hours," said Dr Pan.

"Out of an extreme abundance of caution and also recognizing the extremely limited supply of vaccine, we are recommending that providers use other available vaccine inventory and pause the administration of vaccines from Moderna Lot 041L20A until the investigation by the Centers for Disease Control and Prevention (CDC), US Food and Drug Administration (FDA), Moderna and the state is complete."

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COVID-19 Vaccine

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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All appeared to be experiencing a possible severe allergic reaction during the standard observation period -- a type of adverse event that the CDC reports some people have experienced when receiving a COVID-19 vaccine.

The vaccine site switched to another lot of Moderna vaccine after closing for a few hours.

Moderna said that it is unaware of comparable clusters of adverse events from other vaccination centres which may have administered vaccines from the same lot, or from other Moderna lots.

"Moderna confirmed that a total of 1,272,200 doses were produced in batch number 041L20A, with nearly a million doses (964,900) already distributed to approximately 1,700 vaccination sites in 37 states," the company said in a statement.

While Moderna said it does not know how many doses may have ended up in the arms of people, it did report that the lot was shipped between January 4-8, and thus it expects that a significant portion of the distributed doses have already been used.

Moderna said a detailed review of the manufacturing intermediates and final drug product was performed including raw materials, batch records, release and characterization testing results, and Moderna shipping and storage records.

"The review confirmed that all criteria for product release of lot 041L20A were met," the statement added.
IANS
first published: Jan 20, 2021 06:53 pm

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