3 To Know: Second booster, ALS drug questioned

Marco Eagle
The Food and Drug Administration has authorized another booster dose of the Pfizer or Moderna COVID-19 vaccine for people age 50 and up.

1. FDA OKs 2nd booster for those over 50

U.S. regulators have authorized another COVID-19 booster for people age 50 and older, a step to offer extra protection for the most vulnerable in case the coronavirus rebounds.

The Food and Drug Administration’s decision opens a fourth dose of the Pfizer or Moderna vaccines to those people at least four months after their previous booster.

Until now, the FDA had cleared fourth doses only for people 12 and older who have severely weakened immune systems. The agency said this especially fragile group also can get an additional booster, a fifth shot.

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The latest expansion, regardless of people’s health, allows an extra shot to millions more Americans – and the question is whether everyone who’s eligible should rush out and get it. The Centers for Disease Control and Prevention is expected to weigh in.

The move comes at a time of great uncertainty. COVID-19 cases have dropped to low levels after the winter surge of the super-contagious omicron variant. Two vaccine doses plus a booster still provide strong protection against severe disease and death, CDC data show.

But an omicron sibling is causing causing a worrisome jump in infections in Europe – and spreading in the U.S. – even as vaccination has stalled. About two-thirds of Americans are fully vaccinated, and half of those eligible for a first booster haven’t gotten one.

Pfizer had asked the FDA to clear a fourth shot for people 65 and older, while Moderna requested another dose for all adults “to provide flexibility” for the government to decide who really needs one.

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2. Regulators skeptical of ALS drug benefits

Federal health regulators issued a negative review of an experimental drug for the debilitating illness known as Lou Gehrig’s disease, after months of lobbying by patient advocates urging approval.

The drug from Amylyx Pharmaceuticals has become a rallying cause for patients with the deadly neurodegenerative disease ALS, their families and members of Congress who’ve joined in pushing the Food and Drug Administration to greenlight the drug.

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But regulators said in a review the company’s small study was “not persuasive,” due to missing data, errors in enrolling patients and other problems. On Wednesday, a panel of FDA advisers will take a non-binding vote on whether the drug warrants approval.

The meeting is being closely watched as an indicator of the FDA’s approach to experimental drugs with imperfect data and its ability to withstand outside pressure.

The FDA’s negative stance on the drug sets up a tense scenario at Wednesday’s public session, where several dozen ALS patients and advocates are scheduled to speak. The agency will consider the input from its advisory panel before making a final decision on the drug, expected by June.

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The average cost statewide for gasoline was $4.12 per gallon, with the average cost for a fill-up at $62 for a 15-gallon tank, according to AAA.

3. Where are Florida gas prices heading?

Florida gasoline prices have been slowly trending downward, but maybe not for much longer.

That’s according to the latest gas prices briefing released by AAA-The Auto Club Group.

“Global fuel supply concerns continue driving extreme volatility in the fuel market, leading to big swings in the price of oil,” AAA spokesman Mark Jenkins said.

Crude oil remains almost $10 per barrel less than the 2022 high, he said. That translates to a 25 cent drop at the pump, which already happened in the past two weeks.

“After seeing strong drops two weeks ago, oil rebounded last week to a level that should cause falling gas prices to level off,” Jenkins added.

“Despite the recent dip, pump prices remain 93 cents per gallon more than the 2022 low and 1.93 per gallon more than the lowest price in 2021,” it said.

The average cost statewide for gasoline was $4.12 per gallon, with the average cost for a fill-up at $62 for a 15-gallon tank, according to AAA.

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