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FDA Authorizes Fourth Pfizer and Moderna COVID Vaccine Doses for People Age 50 and Older
The Food and Drug Administration has authorized fourth Pfizer and Moderna COVID vaccine doses for everyone age 50 and older, amid uncertainty over whether an even more contagious version of Omicron will cause another wave of infection in the U.S. as it has in Europe and China.
The FDA also said it authorized a second Pfizer booster shot for people age 12 and older who have compromised immune systems, and a second Moderna booster for adults ages 18 and older with compromised immune systems. The new boosters are administered at least fourth months after the last shot.
The FDA made the decision without a meeting of its vaccine advisory committee, a rare move the agency has made more frequently over the course of the pandemic to expand the uses of already-approved COVID vaccines.
Dr. Paul Offit, a committee member, criticized the drug regulator for moving forward without holding an open meeting where the American public can hear experts weigh the data and make a recommendation to the FDA about the best path forward. “It’s just sort of fait accompli,” Offit said of the FDA authorization. “So is this the way it works? We talk endlessly about how we follow the science — it doesn’t seem to work out that way.”
WHO Examining Potential Hearing Problems Linked to COVID Vaccines
The World Health Organization is examining rare reports of hearing loss and other auditory issues following COVID-19 vaccinations.
People who reported tinnitus ranged in ages from 19 to 91, and nearly three-quarters were women. The reports came from 27 countries, including Italy, the United Kingdom and the United States. More than a third were reported among those working in the healthcare industry.
There is no known cause for tinnitus, and so far, there is no proof that the vaccines may cause any hearing problems, according to the WHO, the Centers for Disease Control and Prevention, and companies that manufacture the vaccines.
A spokesperson from Pfizer later told NBC News that the company found “no causal association” between its COVID vaccine and reports of tinnitus.
Cruise Ship in San Francisco Docks With Multiple Passengers Testing Positive for COVID
A cruise ship that went to the Panama Canal returned to San Francisco on Sunday morning with multiple passengers who tested positive for COVID-19. The Ruby Princess returned to San Francisco from a 15-day trip to the Panama Canal, according to FOX San Francisco.
Vaccination rates between the crew and guests were at 100%, and a cruise spokesperson said that all COVID-19 cases from passengers were mildly symptomatic or asymptomatic, according to the report.
Passengers who contracted COVID-19 and have not completed the quarantine period will get home through private transportation or are being provided with hotel rooms.
Majority of U.S. Population Has COVID Antibodies, CDC Says — Here’s What That Means for You
According to a Centers for Disease Control and Prevention survey of blood donor samples, conducted in December and updated last month, an estimated 95% of Americans ages 16 and older have developed identifiable COVID antibodies. Those come from both vaccinations — roughly 77% of the U.S. population has received at least one COVID vaccine dose, according to the CDC — and prior COVID infections.
Antibodies from vaccinated individuals tend to decline after about four to six months post-shot, says Dr. Timothy Brewer, a professor of medicine in the division of infectious diseases at the David Geffen School of Medicine at UCLA. So if you got a booster dose in December, your antibody boost will probably wear off between April and June.
The data around so-called “natural immunity” is much more of a mixed bag.
According to an October 2021 study by the Yale School of Public Health, published in The Lancet Microbe, unvaccinated people could have immunity against reinfection for anywhere from three to 61 months after getting COVID.
How Do You Stop Fake News About COVID? Not by Silencing Scientists Who Ask Difficult Questions
Carl Heneghan is an epidemiologist first and foremost, professor of evidence-based medicine at Oxford, probably many other things — good citizen, well-liked family member — and then, way down the list, a person on Twitter.
In other words, he doesn’t create social media storms for fun, nor does he have any track record of contrarianism. So how does such a person get banned, as Heneghan was briefly last week, from a social media platform that, famously, has trouble keeping abreast of racial slurs and death threats?
Heneghan published a study that suggested the number of people who had died from COVID may have been exaggerated. His final conclusion was that we still had no idea how many people have died because UK health statistics agencies use inconsistent definitions. This was enough to mark him out, albeit briefly, as a COVID denier, which in turn put him in the same camp as anti-vaxxers.
World Moves From Shortages to Possible Glut of COVID Vaccines
After racing to build capacity and meet once seemingly insatiable orders for COVID-19 shots, the global vaccine industry is facing waning demand as many late-to-market producers fight over a slowing market.
The trend is poised to rein in the blockbuster sales that global pharmaceutical giants from Pfizer Inc. to AstraZeneca Plc saw at the peak of the pandemic. It also stands to create new problems for local manufacturers from India to Indonesia that built mammoth capacity to make shots but is now grappling with excess supply.
Even as boosters are likely to keep demand alive for COVID inoculations worldwide, the desperate shortages that existed for much of last year have waned. Instead, in a dramatic reversal, the possibility of a global glut is now looking more likely.
COVID Deaths at Lowest Point Since Last Summer
The lowest daily average total of deaths from COVID-19 has been recorded since before the Omicron variant swept the U.S. in the fall of 2021.
Fewer than 800 deaths per day due to the coronavirus are being reported on average, which is the lowest number since the middle of last August, The New York Times reports.
The new BA.2 Omicron subvariant, which is to blame for rising cases in Europe, currently accounts for 35 percent of infections in the United States, according to the Times. The newspaper notes that COVID-19 cases have started to rise once again in Kentucky, New York, Colorado and Texas during the past two weeks.
More Contagious Omicron BA.2 Subvariant Now Dominant in the U.S., CDC Says
The more contagious Omicron subvariant, BA.2, is now the dominant version of COVID-19 in the U.S., according to data released by the Centers for Disease Control and Prevention this week.
The subvariant accounts for nearly 55% of COVID infection samples that have undergone genetic sequencing. Even so, the spread of a more contagious strain does not guarantee the U.S. will endure a new wave of cases.
The BA.2 subvariant spreads about 75% faster than the earlier version of Omicron, BA.1, according to the latest update from the U.K. Health Security Agency. BA.2 has caused a spike in infections in the U.K. and Germany in recent weeks, though cases have started to decline again there.
White House Turns to Air Quality in Latest Effort to Thwart Coronavirus
The White House is pivoting to emphasize that poorly ventilated indoor air poses the biggest risk for coronavirus infections, urging schools, businesses and homeowners to take steps to boost air quality — a move scientists say is long overdue and will help stave off future outbreaks.
“Let’s Clear the Air on COVID,” a virtual event hosted Tuesday by the White House science office, comes after President Biden’s coronavirus response team and other leaders have elevated warnings that airborne transmission is the primary conduit of coronavirus infections, a reversal of earlier federal guidance.
As state and local leaders roll back vaccination and mask mandates, experts say improving indoor air quality is increasingly essential as a tool to contain coronavirus risks.
Pfizer Tells Portage Workers to Refund Company After Hack Causes Some to Be Overpaid
Pfizer employees say they’re frustrated and angry over a payroll mistake that could force them to give back money some have already spent.
One employee provided News Channel 3 with a letter and documents received last week that showed Pfizer telling the employee they owed more than $800 in overpayment. Another employee said the issue is affecting hourly workers all across the company.
Pfizer said the overpayments happened following a ransomware attack on Ultimate Kronos Group in December 2021. Pfizer uses Kronos to track the hours that employees work and pay them. According to Pfizer’s letter, affected workers can choose to repay the money over one, three, or six months.
Pfizer, which produced one of the three COVID-19 vaccines available in the U.S., reported more than $80 billion in revenues for 2021 and 92% operational growth. It was also the first COVID-19 vaccine to receive emergency use authorization from the U.S. Food and Drug Administration.
Biden Administration to Offer COVID Vaccines to Migrants
The Biden administration will offer COVID-19 vaccines to migrants taken into custody at the U.S.-Mexico border, according to two sources familiar with the planning, and confirmed by the Department of Homeland Security, as officials prepare for an influx of migrants.
The plan, which had earlier been a source of tension at the White House, could extend to thousands of migrants encountered at the U.S. southern border.
The Department of Homeland Security will be able to initially provide up to 2,700 vaccines per day, it said in a notice to Congress obtained by CNN, increasing to 6,000 daily by the end of May.
Explainer: Why Are Shanghai’s COVID Infections Nearly All Asymptomatic?
Epidemiologists examining the biggest Chinese outbreak of COVID-19 in two years are trying to ascertain why the proportion of asymptomatic cases is so high, and what it could mean for China’s future containment strategy.
The number of new confirmed community transmitted cases in the major financial hub of Shanghai reached 4,477 on Tuesday, a record high, but only 2.1% showed symptoms. The share of symptomatic cases over the previous seven days was around 1.6%.
China is the only major country to do mass, untargeted surveillance testing, which is bound to uncover more asymptomatic cases, although it could also be expected to reveal more symptomatic cases.
UK Study to Test Pfizer’s COVID Pill in Hospitalized Patients
Pfizer‘s (PFE.N) oral COVID-19 therapy will be evaluated as a potential treatment for patients hospitalized with the illness in a major British trial, scientists said on Monday, as cases rise in some parts of the world.
The world’s largest randomized study of potential medicines for COVID-19, dubbed the RECOVERY trial, will assess Paxlovid across hospitals in Britain, which has already approved the drug for early-stage treatment.
The scientists said they aim to mainly find whether Pfizer’s Paxlovid reduces the risk of death among patients admitted to hospitals with COVID-19.
