Why California Paused Large Numbers of Moderna COVID-19 Vaccines



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A single batch of the Moderna COVID-19 vaccine is under investigation. Paul Hennessy / NurPhoto / Getty Images
  • Health officials should stop using a specific lot of Moderna vaccine.
  • Fewer than 10 people developed allergic reactions after receiving this vaccine.
  • All those affected were successfully treated.

Health officials in California have asked health care providers to withhold vaccinations from a single batch of Moderna vaccine after six people in San Diego had severe allergic reactions after receiving the vaccine.

The people required medical attention after receiving the vaccine, according to a statement from the California Department of Public Health (CDPH).

There were no other groups or adverse events associated with the lot (Moderna Lot 041L20A).

More than 330,000 doses of the vaccine had been distributed to 287 suppliers across California by early January.

The batch contained a total of 1,272,200 doses, most of which were shipped across the country, according to a statement from Moderna.

Thousands of these doses have already been administered.

Severe allergic reactions to vaccines are rare, with vaccine-related anaphylaxis occurring in approximately 1 in 100,000, according to the Centers for Disease Control and Prevention (CDC).

However, the vaccine is new and health officials are closely monitoring allergic reaction rates.

But out of caution, the CDPH recommends that California suppliers administer further batches until the state, Moderna, CDC, and the Food and Drug Administration (FDA) investigate the batch in question.

The CRPD ordered an investigation out of caution.

“It is quite normal that a pause on a batch be ordered when there are more possible or unusual reactions,” said Dr Anne Liu, infectious disease physician at Stanford Health Care.

Liu said it was difficult to make any assumptions about the lot until more data became available.

Although this is very unusual, there is a possibility that the Moderna batch has manufacturing irregularities that other batches do not contain.

“Moderna, unlike Pfizer, has outsourced its manufacturing because it is not a large company with a manufacturing infrastructure,” Liu said.

It is also possible that the group of reactions is pure coincidence and not related to the vaccines.

“The clustering of allergic reactions at the same vaccination site could be caused by other phenomena – for example, healthcare workers may have all been pre-exposed to something in their community or work environment that affects them. made them more vulnerable to an allergic reaction, ”said Kathryn A Whitehead, PhD, associate professor of chemical and biomedical engineering at Carnegie Mellon University.

It is also possible that nothing is wrong with the Moderna bundle.

California has experienced a slow and delayed vaccine rollout over the past two weeks.

Where some states, like West Virginia and North Dakota, have already used more than half of their doses, California has only administered 30% of what the state has received.

Suspending the use of the Moderna batch would further delay the state’s vaccination efforts.

“I don’t necessarily think there’s a need to pause the game,” said Dr. Amesh Adalja, a senior researcher at the Johns Hopkins University Center for Health Security and an infectious disease specialist.

Withholding doses during a critical period of the pandemic carries risks.

And allergic reactions are easily recognized and easy to treat, said Adalja.

Liu, meanwhile, believes that taking a break from the administration of the batch to investigate any anomalies is the right decision.

“I agree to be careful and take a break from using this batch until more information can clarify this,” Liu said.

The San Diego Community Immunization Clinic reported a cluster of six allergic reactions potentially related to the paused batch.

A Colorado woman also had a reaction to a vaccine from the same batch.

“Thousands and thousands of other Moderna vaccine doses have been administered without any problems so far,” Liu said.

Other clinics will go ahead with vaccinations using other Moderna lots.

Allergic reactions occur with each vaccine.

“The difference here is that allergic reactions to SARS-CoV-2 vaccines are constantly in the news, unlike allergic reactions to influenza, chickenpox and hepatitis vaccines. The benefits of vaccination far outweigh the risk, ”Whitehead said.

Whitehead said if offered a dose of the lot, she would gladly take it, assuming she would be watched for the standard window after the shot.

All allergic reactions reported in San Diego occurred within the standard 15 to 30 minute viewing window.

Allergic reactions occur soon after vaccination. Therefore, people are advised to stay near the vaccination site for 15 minutes.

Allergic reactions are easily recognized and treatable, Adalja said.

“As long as people get their vaccines in places where they are ready to treat immediate allergic reactions, then they should go on and get the shot,” Liu said.

If you are worried about an upcoming vaccination appointment, you can ask your vaccination clinic if the lot under investigation is pending.

Anyone with a history of severe allergic reactions to vaccines should talk to their doctor before receiving the vaccine.

“This report should not dissuade people from getting what could be a life-saving vaccine,” Adalja said.

California officials have advised health care providers in the state to stop giving a batch of Moderna vaccine after a group of people in San Diego had allergic reactions after receiving the vaccine.

The risk of experiencing an allergic reaction after the vaccine is low, but the California Department of Public Health wants to avoid the batch in question as a precaution.

Some experts are concerned that the risks of further delaying vaccination efforts outweigh the risks of rare allergic reactions, as doctors can easily monitor and treat allergic reactions.

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