New development: Two FDA experts say booster shots are not necessary


Summary

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Parturient quam placerat pharetra

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Vitae vel per

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Ad sodales ex vehicula

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fda booster not necessary

Full story

In what could be a dramatic twist to the planned rollout of the United States’ booster shot program, two leading vaccine reviewers at the Food and Drug Administration were among a group of experts who wrote that booster shots were not yet necessary.

The two FDA experts are Drs. Phil Krause and Marion Gruber. They recently announced they would be stepping down from the FDA this fall.

They joined 16 other leading vaccine researchers in the U.S., Britain, France, South Africa and India, as well as scientists with the World Health Organization, to write an opinion piece published Monday.

They concluded the shots are working well despite the extra-contagious delta variant, especially against severe disease. After reviewing worldwide studies regarding vaccine performance began surging, the team concluded “none of these studies has provided credible evidence of substantially declining protection against severe disease.”

The experts suggest it would be better to create booster shots that better match circulating variants, similar to what happens every year with the flu vaccine, rather than just giving extra doses of the original vaccine.

“There is an opportunity now to study variant-based boosters before there is widespread need for them,” the experts wrote.

The U.S. already offers an extra dose of the Pfizer or Moderna vaccines to people with severely weakened immune systems. For the general population, the debate is boiling down to whether boosters should be given to block milder “breakthrough” infections among the fully vaccinated.

In the opinion piece, the experts concluded “reductions in vaccine efficacy against mild disease do not necessarily predict reductions in the efficacy against severe disease.” They went on to write “even in populations with fairly high vaccination rates, the unvaccinated are still the major drivers of transmission”.

The White House’s plan to begin rolling out boosters later this month would only happen if both the FDA and Centers for Disease Control and Prevention agree. Advisers to the FDA will weigh evidence about an extra Pfizer shot Friday at a key public meeting.

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Why this story matters

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The players

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Community reaction

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Bias comparison

  • The Left pharetra lacinia varius quam venenatis porttitor vivamus nibh amet himenaeos erat fermentum ipsum, ultrices iaculis mus dui ac auctor semper tortor senectus pulvinar.
  • The Center blandit taciti augue torquent egestas massa consequat non lacus, ultrices nullam semper viverra rutrum inceptos urna.
  • The Right velit a cras etiam vivamus aenean tellus adipiscing leo sociosqu mauris amet, convallis tortor ad hac eu eget sodales euismod nullam ridiculus.

Media landscape

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Key points from the Left

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Key points from the Center

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Key points from the Right

  • Curae nam aliquam facilisis elementum quisque volutpat etiam massa maximus nostra primis iaculis tristique habitasse, netus gravida pharetra parturient ornare adipiscing tortor curabitur congue convallis risus tincidunt nullam.
  • Vehicula ultricies dui facilisi lorem conubia nostra blandit id, egestas dolor sem euismod sodales tempor consectetur, augue tempus cubilia felis ex ridiculus mauris.
  • Luctus hendrerit rutrum dapibus auctor laoreet mi commodo sociosqu ligula etiam blandit nascetur, placerat tempor habitasse porta habitant dictum ex dui maximus praesent.

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Timeline

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fda booster not necessary

Summary

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Full story

In what could be a dramatic twist to the planned rollout of the United States’ booster shot program, two leading vaccine reviewers at the Food and Drug Administration were among a group of experts who wrote that booster shots were not yet necessary.

The two FDA experts are Drs. Phil Krause and Marion Gruber. They recently announced they would be stepping down from the FDA this fall.

They joined 16 other leading vaccine researchers in the U.S., Britain, France, South Africa and India, as well as scientists with the World Health Organization, to write an opinion piece published Monday.

They concluded the shots are working well despite the extra-contagious delta variant, especially against severe disease. After reviewing worldwide studies regarding vaccine performance began surging, the team concluded “none of these studies has provided credible evidence of substantially declining protection against severe disease.”

The experts suggest it would be better to create booster shots that better match circulating variants, similar to what happens every year with the flu vaccine, rather than just giving extra doses of the original vaccine.

“There is an opportunity now to study variant-based boosters before there is widespread need for them,” the experts wrote.

The U.S. already offers an extra dose of the Pfizer or Moderna vaccines to people with severely weakened immune systems. For the general population, the debate is boiling down to whether boosters should be given to block milder “breakthrough” infections among the fully vaccinated.

In the opinion piece, the experts concluded “reductions in vaccine efficacy against mild disease do not necessarily predict reductions in the efficacy against severe disease.” They went on to write “even in populations with fairly high vaccination rates, the unvaccinated are still the major drivers of transmission”.

The White House’s plan to begin rolling out boosters later this month would only happen if both the FDA and Centers for Disease Control and Prevention agree. Advisers to the FDA will weigh evidence about an extra Pfizer shot Friday at a key public meeting.

Tags:

Why this story matters

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A suscipit gravida curae

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Class maximus non

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Nullam arcu leo bibendum

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Synthesized coverage insights across 171 media outlets

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Context corner

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Terms to know

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Bias comparison

  • The Left phasellus parturient class porttitor ac placerat vivamus pulvinar facilisi sit ullamcorper iaculis sociosqu, eleifend mus elementum fringilla gravida donec fusce nec ligula finibus.
  • The Center neque dignissim nisi aptent imperdiet sagittis natoque viverra aliquet, eleifend consequat fusce nam montes per quam.
  • Not enough coverage from media outlets on the right to provide a bias comparison.

Media landscape

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Key points from the Left

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Key points from the Center

  • Vivamus fusce faucibus rutrum nostra bibendum risus facilisis finibus senectus velit neque viverra suscipit auctor mus, egestas vestibulum habitant eleifend cras conubia lacus gravida mollis luctus parturient tortor torquent.

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Key points from the Right

  • Ornare mattis torquent efficitur quis accumsan neque penatibus pulvinar congue velit per massa aenean quam, varius cras leo lobortis hendrerit class dignissim metus ultrices id dictum nascetur facilisis.
  • Fermentum a fringilla scelerisque sollicitudin semper velit auctor aptent, aliquet eu primis ad tincidunt ut sociosqu, ante tristique nullam ullamcorper arcu natoque tempus.
  • Nibh orci finibus facilisi conubia porttitor ac suspendisse dictumst aliquam penatibus auctor venenatis, pellentesque ut quam felis ligula blandit arcu fringilla congue volutpat.

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