The CDC and the F.D.A. Halt Further Injections of the J&J Vaccine Citing Clotting Issues

J&J Vaccine

Federal health officials from the Center for Disease Control (CDC) and the Food and Drug Administration (FDA) called for a temporary halt in using the Johnson and Johnson coronavirus vaccine (J&J Vaccine) while they study a severe illness that developed in six American women.

Both Federal organizations called for an immediate halt to injections of Johnson & Johnson’s coronavirus vaccine (J&J vaccine) across the United States on Tuesday, 4/13/21 after federal health agencies said they needed to examine a rare blood-clotting disorder that emerged in six recipients.  All six who developed this rare disorder were women between the ages of 18 and 48. One woman in Virginia died, and a second woman in Nebraska has been hospitalized in critical condition.

The Decision is Controversial

One of the issues is that the sample size is tiny relative to the number of people in the United States who have already received the vaccine. According to sources, more than seven million people in the United States have received Johnson & Johnson shots.  This number represents less than 1 in one million. According to data from the Centers for Disease Control and Prevention, an additional 10 million doses are on their way to the states. Outside of the United States, Johnson & Johnson said it would delay its vaccine rollout in Europe, where several countries were poised to start administering it this week. South Africa, devastated by a more contagious variant of the virus that emerged there, also suspended the vaccine’s use. Australia announced it would not purchase any doses.

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The CDC and the FDA’s move prompted a debate among public health experts about whether guarding against such a rare disorder was worth the cost. The low percentage of people who have experienced the disease prompted many vaccine appointments to be canceled this week. Additionally, many now believe that public health officials feared that by fueling vaccine hesitancy, fewer Americans could get vaccinated.

One and Done

One of the benefits of the J&J vaccine as it is a one-dose vaccine that can be easily stored. This type of vaccine compares to the other U.S. Vaccines from Pziser and Moderna, two-dose vaccines, and need ultra-cold temperatures to keep the vaccine. The flexibility of the J&J vaccine would have allowed states to create mobile sites in rural areas, which now need to be temporarily stored. Despite the temporary halt of the J&J vaccine, U.S. officials expect to have still enough doses of the COVID-19 vaccine to cover 230 million U.S. adults by the end of May.  There is an expectation in the U.S. that approximately 20% of the population will refuse to take the vaccine. The halt by the FDA and CDC is likely the right decision as the U.S. government is concerned that doctors may not be trained to spot or treat the rare disorder if recipients of the vaccine develop symptoms.

The Impact on J&J is Harmful

The impact on J&J share trading has been harmful. For the United States, most of the nation’s vaccine stock comes from two other manufacturers, Pfizer-BioNTech and Moderna. Those two vaccines use a different technology than Johnson & Johnson’s and another vaccine from AstraZeneca. According to the CDC, more than 180 million doses of Pfizer and Moderna have been administered.

This is the second issue that generated problems for Johnson and Johnson in the past two months. In March, the company discovered that workers at a Baltimore plant had accidentally contaminated a batch of its vaccine, forcing the firm to throw out millions of doses. Johnson & Johnson’s shipments dropped to one-fourth or less of what had been expected, a severe disappointment to White House and state officials.

J&J Vaccine: The FDA and CDC Had No Choice

While the Biden Administration is disappointed, many believe the FDA and CDC had no choice. Scientists with the FDA and the CDC will jointly examine possible links between the vaccine and the disorder and determine whether the FDA should continue to allow the vaccine’s emergency use. Unfortunately, the halt in the rollout has complicated efforts while the virus is beginning to surge again in many states. Regulators in Europe are concerned about a similar issue with another coronavirus vaccine developed by AstraZeneca and Oxford University researchers.

The Bottom Line

The upshot is that the news that U.S. officials had to temporarily halt the administration of the J&J Covid-19 vaccine not only hurts the American people and places a cap on share trading. The U.S. is fortunate to have 2-other vaccines that work differently, made by Pfizer and Moderna, and will likely cover most Americans who want to receive a vaccine. The benefits of the J&J vaccine are that it is a one-dose vaccine, and it can be stored in a refrigerator as opposed to ultra-cold temperatures.

Also Read: Johnson & Johnson vaccine suspension – a doctor explains what this means for you

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