The Food and Drug
Administration (FDA), federal agency of the US’ Department of Health and Human
Services, said on Wednesday that it is wrestling with whether and when recipients
of the single-shot Johnson & Johnson COVID-19 vaccine need another dose —
at six months or as early as two months, according to an Associated Press
report.

Citing
shortcomings in Johnson & Johnson’s data, FDA scientists could not reach a
firm conclusion after conducting an online review. Scientists said the company’s
data has little information on the vaccine’s ability to protect against more
virulent strains of the coronavirus like the Delta variant.

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FDA’s review comes
right ahead of meetings later this week when an advisory panel of the agency
will recommend whether to support booster shots for both the Johnson &
Johnson and the Moderna vaccines.

The FDA is
expected to take a final decision on authorising booster shots next week after
which the Centers for Disease Control and Prevention (CDC) will take a call on
who should get the booster shots. According to health authorities, as of now,
all the vaccines in use in the United States continue to provide strong
protection against severe disease and death from COVID-19.

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However, there are
signs that indicate that the protection of vaccines from milder infection may
be waning. The US government has already cleared booster shots for a certain
section of people starting at six months after their last shot. Moderna has also
asked the FDA to clear its booster shot at six months.

The conflict
primarily is with the Johnson & Johnson vaccine. The company has
complicated the decision by proposing a second dose over a range of two to six
months. FDA reviewers wrote that a study of the two-month booster plan suggests
“there may be a benefit,” while pointing to only small numbers of people who got
another shot at six months instead.

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FDA reviewers concluded
that the Johnson & Johnson vaccine continues to afford protection against
severe COVID-19, disease and death, although the data about its efficacy are
consistently less than the protection seen with Pfizer and Moderna vaccines.

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According to
Johnson and Johnson’s own data, which it has submitted to the FDA, a real-world
study shows that its vaccine remains about 80% active against hospitalisations
in the United States. The Johnson and Johnson vaccine was among the
most-anticipated vaccine in the fight against COVID-19 for its one-dose
formulation. However, rollout of the shots ran into a series of troubles including
manufacturing problems and rare but serious side effects.  

(With inputs from Associated Press)