Pfizer Vaccine Gives 100% Protection at Ages 12-15 in Study

Source: Bloomberg

By Robert Langreth; March 31, 2021, 6:45 AM EDT Updated on 

  •  Company will seek to add adolescents to its FDA authorization
  •  Result could pave way for shots in teens before school reopens

Pfizer Inc. said its Covid-19 vaccine was 100% effective in a final-stage trial in kids ages 12 to 15, a finding that could pave the way for teens and pre-teens to get shots before the next school year.

The vaccine is already authorized in the U.S. for people ages 16 and up. Pfizer and its partner BioNTech SE said they planned to submit the data to regulators in the U.S and Europe as soon as possible, seeking to amend their vaccine authorizations to include the younger age group.

In the study of 2,260 adolescents, the vaccine produced antibodies against the Covid-19 that exceeded the level seen in vaccinated young adults, Pfizer and BioNTech said in a statement. All 18 cases of Covid-19 in the study were in adolescents who were administered a placebo, the companies said. Side effects were consistent with those experienced by people ages 16 to 25.

A Pfizer spokesperson, meanwhile, said the company is in conversations with the U.S. Food and Drug Administration on what the next steps may be. The FDA declined to comment on how quickly it might act on the data.

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Categories: Vaccine

4 replies

  1. A more contagious strain of the coronavirus is now predominant in five U.S. regions and accounts for a quarter of new cases nationally, the head of the Centers for Disease Control and Prevention said.

    The B.1.1.7 variant, first uncovered in the U.K., makes up from 4% to 35% cases depending on the region, and 26% of cases nationally, Rochelle Walensky said at a press briefing Wednesday. U.S. officials had warned it could become the predominant strain of the virus in the U.S. by early April.

    “We’re watching this very carefully but it is starting to become the predominant variant in many U.S. regions,” Walensky said. “We’re starting to see it creep up. We do know it’s more transmissible, somewhere between 50% and 70% more transmissible than the wild type strain, so to the extent people are not practicing the standard mitigation strategies, we do think that more infections will result because of B.1.1.7.”

    Walensky didn’t specify in which regions the strain is now predominant. Mitigation measures such as masking and socially distancing work “just as well” against the variants as they do against the initial form of Covid-19, she said.

  2. A manufacturing error at a plant involved in Covid-19 vaccine production affected 15 million doses worth of an ingredient for Johnson & Johnson’s vaccine, according to two sources familiar with the matter, though the company downplayed the situation and said it met its most recent vaccine delivery target.

    The issue, which occurred recently at an Emergent BioSolutions Inc. facility in Baltimore, isn’t expected to change President Joe Biden’s expectation that the U.S. will have enough vaccine for all adults in May, the people said.

    In a statement, J&J said a batch of drug substance failed its quality test.

    “This quality control process identified one batch of drug substance that did not meet quality standards at Emergent BioSolutions, a site not yet authorized to manufacture drug substance for our Covid-19 vaccine,” J&J spokesman Jake Sargent said in an emailed statement. “This batch was never advanced to the filling and finishing stages of our manufacturing process.”

  3. (CNN)The ongoing Phase 3 clinical trial of Pfizer/BioNTech’s coronavirus vaccine confirms its protection lasts at least six months after the second dose, the companies said Thursday.

    It’s the first look at how long protection for a coronavirus vaccine lasts, and while six months is a modest target, it’s longer than the 90 days of protection been the best estimate offered to date.

    The vaccine remains more than 91% effective against disease with any symptoms for six months, the companies said. And it appeared to be fully effective against the worrying B.1.351 variant of the virus, which is the dominant strain circulating in South Africa and which researchers feared had evolved to evade the protection of vaccines, the companies said.

    “The vaccine was 100% effective against severe disease as defined by the U.S. Centers for Disease Control and Prevention (CDC), and 95.3% effective against severe COVID-19 as defined by the U.S. Food and Drug Administration (FDA),” Pfizer and BioNTech said in a joint statement.

  4. Five countries that turned away more expensive Pfizer Inc. covid doses in favor of a cheaper version from AstraZeneca Plc are paying the price.

    Bulgaria, Croatia, Estonia, Latvia and Slovakia, which declined part of their Pfizer allotments to wait for Astra doses, are among the slowest in the bloc to administer vaccines, according to a European Union document seen by Bloomberg. While Pfizer has met its commitments, Astra has delivered just 30 million of its originally committed 120 million doses in the first quarter.

    As a result, Bulgaria and Croatia are expected to vaccinate 45% of their populations by the middle of the year, according to the document, the lowest in the EU after the Czech Republic. Estonia will vaccinate 50%, Latvia 53% and Slovakia 46%. That compares to 61% in Germany, 80% in Denmark and 93% in Malta.

    The European Commission, the EU’s executive body, said on Wednesday that more than 100 million doses were delivered to its member states in the first quarter, matching its lowered target. The EU expects the pace to pick up in the second quarter when it’s forecast to receive 360 million doses.

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