A Mickey Mantle Baseball Card Sells for $12.6 Million at Auction
Topps baseball cards began a print run for a Mickey Mantle baseball card, but most of those marked number 311 arrived too late for the 1952 season, according to a history of the item from Heritage Auctions.
The unsold stock was eventually destroyed by Topps. As time passed and Mr. Mantle’s fame grew, demand for his baseball cards exploded. Collectors placed a premium on the extremely rare 1952 version marked number 311.
The discovery of the card sold Sunday goes to a pioneer in the sports memorabilia industry, a man named Alan Rosen, who marketed himself as “Mr. Mint.”
Mr. Rosen was contacted in the late 1980s by a man in Boston who claimed his father had been a delivery driver for Topps and had kept a case of baseball cards that were meant to be destroyed, Heritage Auctions said.
He drove to Boston and struck a deal for the memorabilia, known to collectors as the “Rosen Find.” It included multiple number 311 Mickey Mantle cards, one of which Mr. Rosen sold in 1995 to Mr. Giordano.
Mr. Mantle played his entire 18-year career with the Yankees and was inducted into the Baseball Hall of Fame in 1974. He was named Most Valuable Player three times and won the American League Triple Crown in 1956. In his first eight seasons in New York, the Yankees won seven AL pennants and five World Series titles, according to the Hall of Fame.
He retired just before the 1969 season with 536 home runs and a career .298 batting average. In all, he helped the Yankees win seven World Series titles. The Hall of Famer died in 1995 at 63 years old.
The mint condition 1952 Topps card of the Yankees slugger surpasses the previous sports memorabilia record—$9.3 million for Diego Maradona’s ‘Hand of God’ jersey
Mickey Mantle just hit another home run.
A mint condition baseball card of the New York Yankees slugger sold for $12.6 million Sunday—a record price for a piece of sports memorabilia.
The 1952 Topps baseball card was sold through Heritage Auctions by Anthony Giordano, a waste management businessman from New Jersey. He had bought the card at a sports memorabilia show in New York City in 1991 for $50,000.
Mr. Giordano, 75 years old, stopped watching the online auction Saturday night when the price hit $10 million, he told the Associated Press. His sons stayed awake and gave him the final price in the morning, he said.
The closing bid of $12.6 million went to an anonymous buyer. It eclipsed the sports memorabilia record set in May, when someone paid $9.3 million for the jersey worn by Argentine soccer star Diego Maradona as he scored his controversial “Hand of God” goal in the 1986 World Cup.
Earlier this month, a rare, authenticated Honus Wagner T-206 baseball card changed hands for $7.25 million in a private sale. It was the most expensive trading card sold until the Mantle auction on Sunday.
The previous record was set in April 2021 by another Wagner T-206 card, which sold for $6.6 million.
The 1952 Mantle card sold by Mr. Giordano is just one of a handful of the Hall of Famer still in existence and in near-perfect condition.
Its backstory is also legendary within the sports collector world.
In 1951, Mr. Mantle was a rookie from Oklahoma trying to make it in the Major Leagues with the New York Yankees. He was injured while chasing a fly ball in the World Series that year.
But the next season, 1952, he returned to the Yankees as starting center fielder, replacing another Yankee great, Joe DiMaggio. Mr. Mantle became a fan favorite, batting .311 with 23 home runs and 94 runs scored.
Top 10 highest prices paid for sports cards
PLAYER CARD PRICE
1 Mickey Mantle 1952 Topps SGC 9.5 $12.60 million
2 Honus Wagner T206 SGC 2 $7.25 million
3 Honus Wagner T206 SGC 3 $6.60 million
T4 Mickey Mantle 1952 Topps PSA 9 $5.20 million
T4 LeBron James 2003-04 Rookie Patch Auto $5.20 million
6 Luka Doncic* 1:1 Logoman Auto $4.60 million
7 Patrick Mahomes* 2017 Rookie Auto BGS 8.5 $4.30 million
8 Mike Trout 2009 Superfractor Auto $3.90 million
T9 Honus Wagner T206 PSA 2 $3.75 million
T9 Wayne Gretzky 1979 O-Pee-Chee $3.75 million
*Private sale
Note: T=Tie
Source: Actionnetwork.com
A mint condition baseball card of the New York Yankees slugger sold for $12.6 million Sunday—a record price for a piece of sports memorabilia.
The 1952 Topps baseball card was sold through Heritage Auctions by Anthony Giordano, a waste management businessman from New Jersey. He had bought the card at a sports memorabilia show in New York City in 1991 for $50,000.
Mr. Giordano, 75 years old, stopped watching the online auction Saturday night when the price hit $10 million, he told the Associated Press. His sons stayed awake and gave him the final price in the morning, he said.
The closing bid of $12.6 million went to an anonymous buyer. It eclipsed the sports memorabilia record set in May, when someone paid $9.3 million for the jersey worn by Argentine soccer star Diego Maradona as he scored his controversial “Hand of God” goal in the 1986 World Cup.
Earlier this month, a rare, authenticated Honus Wagner T-206 baseball card changed hands for $7.25 million in a private sale. It was the most expensive trading card sold until the Mantle auction on Sunday.
The previous record was set in April 2021 by another Wagner T-206 card, which sold for $6.6 million.
The 1952 Mantle card sold by Mr. Giordano is just one of a handful of the Hall of Famer still in existence and in near-perfect condition.
Its backstory is also legendary within the sports collector world.
In 1951, Mr. Mantle was a rookie from Oklahoma trying to make it in the Major Leagues with the New York Yankees. He was injured while chasing a fly ball in the World Series that year.
But the next season, 1952, he returned to the Yankees as starting center fielder, replacing another Yankee great, Joe DiMaggio. Mr. Mantle became a fan favorite, batting .311 with 23 home runs and 94 runs scored.
Top 10 highest prices paid for sports cards
PLAYER CARD PRICE
1 Mickey Mantle 1952 Topps SGC 9.5 $12.60 million
2 Honus Wagner T206 SGC 2 $7.25 million
3 Honus Wagner T206 SGC 3 $6.60 million
T4 Mickey Mantle 1952 Topps PSA 9 $5.20 million
T4 LeBron James 2003-04 Rookie Patch Auto $5.20 million
6 Luka Doncic* 1:1 Logoman Auto $4.60 million
7 Patrick Mahomes* 2017 Rookie Auto BGS 8.5 $4.30 million
8 Mike Trout 2009 Superfractor Auto $3.90 million
T9 Honus Wagner T206 PSA 2 $3.75 million
T9 Wayne Gretzky 1979 O-Pee-Chee $3.75 million
*Private sale
Note: T=Tie
Source: Actionnetwork.com
Topps baseball cards began a print run for a Mickey Mantle baseball card, but most of those marked number 311 arrived too late for the 1952 season, according to a history of the item from Heritage Auctions.
The unsold stock was eventually destroyed by Topps. As time passed and Mr. Mantle’s fame grew, demand for his baseball cards exploded. Collectors placed a premium on the extremely rare 1952 version marked number 311.
The discovery of the card sold Sunday goes to a pioneer in the sports memorabilia industry, a man named Alan Rosen, who marketed himself as “Mr. Mint.”
Mr. Rosen was contacted in the late 1980s by a man in Boston who claimed his father had been a delivery driver for Topps and had kept a case of baseball cards that were meant to be destroyed, Heritage Auctions said.
He drove to Boston and struck a deal for the memorabilia, known to collectors as the “Rosen Find.” It included multiple number 311 Mickey Mantle cards, one of which Mr. Rosen sold in 1995 to Mr. Giordano.
Mr. Mantle played his entire 18-year career with the Yankees and was inducted into the Baseball Hall of Fame in 1974. He was named Most Valuable Player three times and won the American League Triple Crown in 1956. In his first eight seasons in New York, the Yankees won seven AL pennants and five World Series titles, according to the Hall of Fame.
He retired just before the 1969 season with 536 home runs and a career .298 batting average. In all, he helped the Yankees win seven World Series titles. The Hall of Famer died in 1995 at 63 years old.
Former government adviser calls for overhaul of UK utilities regulators
Dieter Helm attacks privatisation model and says energy and water ‘too essential to be treated like any other commodity’
Britain’s privatisation model for energy and water is “broken”, according to a former Conservative government adviser who has called for an overhaul of the sectors’ regulators.
Sir Dieter Helm, professor of economic policy at the University of Oxford, said that energy and water were “too essential to be treated like any other commodity, as some of the architects of the privatisation, liberalisation and competition paradigm believed”.
“It is not accidental that both the water and the energy privatisation models have run into serious trouble. After more than 30 years, neither is fit for purpose. Nor are their regulators,” he told the Financial Times in an interview.
Speaking as an 80 per cent increase to the energy price cap triggered public outcry over soaring electricity bills last week, Helm said both the watchdog for energy, Ofgem, and water, Ofwat, should be replaced with new wide-sweeping regulators that cover each entire system.
The comments also followed criticism over water companies pouring an unknown quantity of sewage into England’s rivers and seas, and implementing hosepipe bans while wasting water through leaks during a national drought.
Water and energy in the UK should be thoroughly overhauled “based on investment in the assets and the systems, not one based on financial engineering and short-term network price caps,” said Helm.
Both the energy and water sectors had become prone to “revolving doors and pork-barrel politics, heavily influenced by vested interests, with an interest in complexity, which is a lobbyist’s dream,” Helm said.
This had led to the “inevitable consequences of poor regulation and bad outcomes for customers”, he added.
Since 2010, the government has gradually become the main purchaser of all electricity, Helm said, with almost all new generation coming with a state-backed contract or subsidy, which is the “polar opposite of what the architects of privatisation had in mind”.
Helm questioned the predominant narrative that high energy costs are solely the consequence of rising wholesale gas prices owing to the war against Ukraine. Despite not importing much gas directly from Russia, the UK has been among the hardest hit.
“Customers faced with high bills are paying too much because the government failed to reform the market,” said Helm, who wrote the 2017 Cost of Energy review for government.
In terms of solutions, he said the price of electricity should be tied to the cost of production, rather than always to the marginal cost of gas, which had enabled many renewable producers to make “supernormal profits” linked to the higher price of gas while their own costs “haven’t changed one iota”.
This was “every bit as much an unearned windfall as the oil and gas producers are getting”, he said.
Although the government should press ahead with added windfall taxes on renewable and nuclear energy generators “you wouldn’t need this if you had a proper tax regime for the North Sea or an electricity market, which is priced on the basis of costs,” he said. Many of these measures are “sticking plasters on a failed model,” Helm added.
The UK will still need to rely on gas in the short term, he said because of the intermittency of wind energy, and the fact that new technologies such as battery storage will not be able to compensate for at least a decade.
He added that wind power was also not necessarily the cheapest form of energy at present once the intermittency and network costs are added back in.
“Ofgem is not the right vehicle,” Helm said. “Energy needs system regulation, not an institutional muddle with Ofgem in overall charge.”
On the water sector, the former government adviser called for a new system of regulation based on catchment areas, which would cover everything from flood management to water supplies, leakage and the protection of the environment.
This body would be in the public, not private sector, but be given independence and encouraged to put work out to competitive tender, as most water companies already subcontract labour. “If you did that I don’t really care whether they are nationalised or not,” Helm said.
Ofgem said: “We are confident Ofgem regulation is robust — tackling any unfair practices by suppliers and putting consumer protection at the heart of what we do.”
Ofwat declined to comment.
White House believes new Covid-19 vaccines will be key to controlling a potential fall surge; New COVID-19 booster shot campaign anticipated to begin early September, but both PFE-BNTX and MRNA booster shots target omicron BA.4 and BA.5 subvariants not BA.6
- The White House is rushing ahead to roll out a new COVID-19 booster shot campaign in early September, but is facing an uphill battle to ensure it is successful.
- The vaccines being used in the campaign are the first ones that have been manufactured to specifically target the subvariants of omicron that are currently causing the most infections, and administration officials have indicated they’re preparing to start offering the shots shortly after Labor Day.
- Immunity from the initial round of vaccines is waning and health officials said they want to ensure the public is protected as much as possible against another wave of infections in the fall and winter. Right now, close to 450 Americans are dying every day from the virus, and there’s concern the numbers could rise as people move indoors.
- Both Pfizer and Moderna have asked the Food and Drug Administration (FDA) for emergency use authorization for booster shots that target the omicron BA.4 and BA.5 subvariants. Pfizer’s vaccine will be for everyone aged 12 and older, while Moderna’s will be meant just for adults aged 18 and older.
- During an interview with the radio program “Conversations on Health Care,” Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky said the administration wants to provide people with the broadest possible protection.
- “So the strategy now is to tailor vaccine for giving us the largest breadth of response, ideally one that would have less waning over time,” Walensky said. “I believe it is best to use a vaccine that is tailored for the variant that we have right now.”
- But despite the administration’s optimism, the effort is likely to face major hurdles. Chief among them is a lack of interest from the public. Only about two-thirds of the U.S. population have been vaccinated with a primary COVID-19 vaccine series, while less than half of that group has received even a first booster.
- The vaccination rate among children is even lower. According to the CDC, less than 4 percent of eligible kids under the age of 2 have received at least one dose, and only 6 percent of kids between the ages of 2 and 4 have received a single dose.
- The same people who rushed to get the initial vaccine series and then the first round of boosters will be the ones to receive the omicron-specific shots, she said, and mixed messages from health officials are partly to blame.
- The most recent update to the CDC’s guidance emphasized living with the virus, and downplayed many of its previously recommended mitigation strategies. That doesn’t necessarily mesh with the idea that the public urgently needs to get an updated vaccine.
- Rather than a broad rollout of the updated vaccines for the general public, Limaye and other scientists have suggested a more targeted approach, tailoring vaccine recommendations to the elderly and immunocompromised.
- It is important that health officials provide the public with realistic messaging, and don’t oversell the benefits of the shots.
- The other concern among some scientists is that the government is moving too quickly to authorize the vaccines. Neither Moderna nor Pfizer has clinical trial data for the vaccine. Instead, their requests are based on data from a booster targeting an earlier version of omicron, as well as preclinical data from mice.
- But health officials maintain they don’t need additional data, because vaccine manufacturers are essentially making a minor update to the existing vaccine, which has an established track record of success.
- Much is still unclear about BA.4.6, a descendent of the BA.4 variant that first emerged in April and May. The new strain is now responsible for just over 5% of cases across the country, according to Centers for Disease Control and Prevention estimates, marking a slight increase from numbers reported one week earlier.
Health Secretary Steve Barclay orders some 26M UK residents should receive new 'variant-busting' Covid booster by December in effort to ease seasonal pressure on the National Health Service
- There are no plans as of yet to administer a fourth dose to those under the age of 50, NHS England has confirmed.
- The vaccine to protect the most vulnerable against Omicron will begin its roll out in a week
- the same day that Liz Truss is expected to be confirmed at the new UK prime minister.
- As of yet, the Joint Committee on Vaccination and Immunisation has decreed that no younger age groups than the most vulnerable should be offered the extra layer of protection. An NHS England source, said: “They decide who is eligible for the jabs and we deliver them.”
- The NHS will be the first healthcare system across the globe to use a bivalent, which protects both against the prevalent Omicron strain and the original virus types. Staff of care homes and residents alike, as well as those who are housebound will be the first in line to receive their jab starting a week today.
- And the following week, the National Booking Service will be open for those aged 75 and over to determine an appointment. Those who are immunosuppressed will also be able to walk into their local GP surgery or pharmacy to have their dose on request.
National Hurricane Center (NHC): Sees 70% chance of cyclone formation in next 5 days in Central Tropical Atlantic
- A broad and elongated area of low pressure is located over the central tropical Atlantic Ocean. Although the associated shower and thunderstorm activity has increased somewhat since yesterday, it currently lacks organization. Environmental conditions are expected to be generally conducive for gradual development, and a tropical depression is likely to form later this week while moving toward the west and then west-northwest at around 10 mph, toward the waters east of the Leeward Islands.
EU set to agree on suspension of visa travel agreement on preferential treatment with Russia on Aug 30th as a first step to curb Russian travel permits - FT
- Decision set to be taken at meeting of foreign ministers in Prague would remove preferential treatment for Russians and make EU visas more expensive, require more documentation and have longer waiting times
- Deeper changes reportedly could be introduced by the end-2022
Western Countries Breathe New Life Into Old Nuclear Plants
Governments seek to stop reactors from shutting down and to restart idled ones in move to bolster energy supplies and meet climate targets
The West has begun to muster the money and political support to keep decades-old nuclear reactors from shutting down, aiming to maintain a crucial source of low-carbon electricity as many economies face an energy crunch.
The U.S., France and a handful of other countries are planning to keep dozens of reactors running decades after their original operating licenses expire. Belgium is moving to allow two reactors that were set to close in 2025 to operate until 2036 to help Europe wean itself off Russian natural gas after the invasion of Ukraine.
Germany, which was set to close all its reactors by the end of the year, is now debating whether to keep the last three open into next year to help save gas through the winter as Moscow has sharply cut shipments of the fuel. Some politicians are calling for the reactors to remain open even longer.
Japan’s prime minister this week called for the country to reopen more of its nuclear reactors because of the high price of natural gas, after the country idled most of them in the aftermath of the 2011 meltdowns at the Fukushima Daiichi plant.
Those moves reflect a growing consensus that the global economy needs every megawatt of nuclear energy available to bolster energy supplies and help meet United Nations climate targets, which call for global net greenhouse-gas emissions to fall to zero by the middle of the century.
Natural-gas prices have soared as Russia clamps down on exports of the fuel, softening antinuclear sentiment in countries such as Germany and Japan that import lots of gas. Maintaining and replacing equipment for an existing reactor is also far cheaper and simpler than building a new one. Western nations have spent tens of billions of dollars over the past decade on a handful of new reactors that are years behind schedule and billions over budget.
France is proposing to build up to 14 new large reactors in the coming decades. The U.K., the Czech Republic, Poland and other countries are planning to build new reactors as well. Utilities in the U.S. and Europe are considering building small modular reactors that backers say will be easier to build than larger ones. But these projects are likely at least a decade away from delivering power to customers, analysts say.
The cost of keeping reactors open also compares favorably with replacing them with other low-carbon sources of electricity such as wind turbines and solar panels that suffer from the unpredictability of the elements, says the International Energy Agency. Nuclear power produces close to zero emissions of carbon dioxide, the main gas that scientists say is causing the Earth to warm.
“Extending nuclear plants’ lifetimes is an indispensable part of a cost-effective path to net zero by 2050,” the IEA said in a report published this summer. “Yet decisions about how long to operate these plants threaten to erode that foundation.”
Some reactors are closing anyway. The U.K.’s Hinkley Point B plant shut for good on Aug. 1, despite suggestions from some U.K. lawmakers that it could be kept open to bolster energy supplies through the winter. U.K. ministers said they didn’t ask the plant’s owner, EDF Energy, a subsidiary of French state-controlled power giant EDF SA, to run it longer. All the U.K.’s other reactors are set to close by 2028, though EDF Energy has said it is reviewing whether to seek a 20-year operating extension for another reactor it owns.
Local officials in Canada are moving ahead with the shutdown of the Pickering plant in Ontario starting in 2024. The Palisades nuclear plant in Michigan shut in May. The Diablo Canyon plant, which generates around 8% of California’s electricity, is slated to begin shutting down in 2024, but Gov. Gavin Newsom has proposed keeping it open until 2029 and possibly longer.
There are technical and financial obstacles to prolonging the lives of reactors. In the U.K., EDF Energy has been monitoring the appearance of cracks in graphite blocks in the reactor cores. The problem is specific to the U.K.’s main reactor design, which isn’t used anywhere else in the world. EDF Energy says the cracks cannot be repaired.
In the U.S., 13 U.S. nuclear reactors have shut since 2013, largely because the low cost of alternative fuels such as natural gas rendered nuclear energy unprofitable.
State governments in recent years have provided subsidies to stop closures. U.S. climate legislation signed into law this month offers tax credits to help nuclear reactors stay open, with an estimated cost of $30 billion over the next decade.
Keeping reactors running beyond the period covered by their initial operating license—usually 40 years—entails major investments to ensure safety. Large components need to be replaced, and some regulators are requiring new safety measures to respond to the meltdowns at the reactors in Fukushima. France, which has the largest nuclear fleet in Europe, is spending €50 billion, or about $50 billion, to ensure that all 56 of its nuclear reactors can continue operating after 40 years.
Nuclear-plant owners also need to take account of the growing risk that climate change poses to their operations, officials say. Almost all nuclear plants are located next to the sea or rivers to supply vast quantities of water for generating electricity and cooling the reactor core. That makes them potentially vulnerable to the effects of rising sea levels, increasing drought and higher storm intensity.
This summer, France lowered production at several reactors because the river water they use to generate electricity was too low and too warm.
Near the southern tip of Florida, the Turkey Point nuclear power plant sits on land that scientists say is threatened by rising seas and more powerful storms as the Earth warms. It also holds the first reactor in the world that the nuclear industry has proposed to keep operating for up to 80 years, placing it at the leading edge of the debate.
The U.S. Nuclear Regulatory Commission in 2019 approved a 20-year extension of the operating license for the plant’s two reactors, the second 20-year extension received by the plant after its original 40-year license expired. The NRC did so using an environmental analysis by the plant’s owner, NextEra Energy Inc. subsidiary Florida Power & Light, that was based largely on a template for the plant’s previous 20-year extension.
Earlier this year, the NRC reversed that decision after environmentalists challenged it, ruling that the analysis wasn’t sufficient to comply with the law. Environmental groups say the plant’s cooling system—a large network of canals next to the plant—is at risk of more powerful storm surges, threatening sensitive habitats in Biscayne Bay and the Everglades near the plant.
“We’ve got a lot of old plants being exposed to extreme weather,” said Caroline Reiser, an attorney at the Natural Resources Defense Council, one of the environmental groups that challenged the decision. “It’s kind of a dangerous combination to be ignoring.”
Florida Power & Light says the plant is elevated 20 feet above sea level and has a host of measures to protect it from flooding, including a three-foot-thick, steel-reinforced concrete building housing the reactor that is sealed. After the accident at Fukushima, the company submitted a study to regulators concluding that the plant could withstand severe flooding, including a storm surge bigger than the one produced by Hurricane Andrew, one of the most powerful storms ever recorded in the U.S.
“If new information about changing environmental conditions becomes available, FPL and the NRC will evaluate the new information to determine if any safety-related changes are needed at its nuclear power plants,” said company spokesman Bill Orlove.
U.S. Warships Sail Through Taiwan Strait for First Time Since Nancy Pelosi’s Visit
Move comes as tensions rise between Taiwan and China following the U.S. House speaker’s trip earlier this month
HONG KONG—Two U.S. warships sailed through the Taiwan Strait, U.S. and Taiwan defense officials said Sunday, the first such activity publicized since U.S. House Speaker Nancy Pelosi visited Taiwan earlier in August.
The voyage “demonstrates the United States’ commitment to a free and open Indo-Pacific,” the U.S. Navy’s 7th Fleet said. “The United States military flies, sails, and operates anywhere international law allows.”
The U.S. Navy said the USS Antietam and USS Chancellorsville are conducting a routine transit, with the cruisers passing through ”a corridor in the strait that is beyond the territorial sea of any coastal state.”
China monitored the movement of the U.S. ships, said Senior Col. Shi Yi, spokesman for the People Liberation Army’s Eastern Theater Command. He said Chinese troops should remain alert and be ready to defeat any provocation at any time.
The U.S. move comes amid deteriorating ties between Beijing and Washington and as tensions rise between Taiwan and China following Mrs. Pelosi’s trip to Taipei to meet with Taiwanese President Tsai Ing-wen over Beijing’s objections.
Immediately after Mrs. Pelosi’s visit, Beijing launched missiles over Taiwan and encircled the island with military drills simulating a blockade.
China’s Communist Party, which has never ruled Taiwan, claims the island as part of its territory and has vowed to take control of it, by force if necessary.
Taiwan on Thursday unveiled plans to boost military spending by its largest margin in 15 years. This came a day after China announced plans for live-fire military drills on Friday and Saturday off the coast of Fujian, the southeastern province closest to Taiwan.
Taiwan’s Ministry of National Defense on Sunday said eight Chinese Navy vessels and 23 Chinese aircraft were detected in its surrounding region. It said its military forces monitored the situation and responded with aircraft, naval vessels and land-based missile systems.
Latest Covid Boosters Are Set to Roll Out Before Human Testing Is Completed
The FDA and vaccine makers say they are confident that shots targeting Omicron subvariants will work safely
The Food and Drug Administration is expected to authorize new Covid-19 booster shots this week without a staple of its normal decision-making process: data from a study showing whether the shots were safe and worked in humans.
The shots, modified to target the latest versions of the Omicron variant, won’t have finished testing in humans when the FDA makes its decisions.
Instead, the agency plans to assess the shots using data from other sources such as research in mice, the profiles of the original vaccines and the performance of earlier iterations of boosters targeting older forms of Omicron.
“Real world evidence from the current mRNA Covid-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe,” FDA Commissioner Robert Califf said in a recent tweet. The FDA pointed to Dr. Califf’s tweets when asked for comment.
Clearance of the doses, without data from human testing known as clinical trials, is similar to the approach the FDA takes with flu shots, which are updated annually to keep up with mutating flu viruses.
The approach has raised concerns, however, among some vaccine experts who have urged the agency to wait.
“I’m uncomfortable that we would move forward—that we would give millions or tens of millions of doses to people—based on mouse data,” said Paul Offit, an FDA adviser and director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
The comparison with flu vaccines isn’t sound, Dr. Offit said, because flu viruses mutate so rapidly that shots from one year don’t offer protection for the next, while currently available Covid-19 shots continue to keep people out of the hospital.
In addition to evaluating the boosters without clinical-trial data, the FDA won’t convene another element from its earlier Covid-19 vaccine reviews: a meeting of advisers who make recommendations whether the agency should authorize a shot.
The FDA scrapped the meeting, Dr. Califf said in his tweets on the subject, because the committee discussed the matter in June, and the agency doesn’t have new questions warranting its input.
The Covid-19 vaccines available in the U.S., which were first authorized for use in December 2020, haven’t been modified until now, though the virus they were designed to target has evolved.
The shots held up well against earlier strains, researchers found, but weren’t as effective against the newest Omicron subvariants like BA.5.
In planning for a fall booster campaign, federal health authorities in late June directed Pfizer Inc. and its partner BioNTech SE, and Moderna Inc. to update their shots to target BA.5, an Omicron subvariant called BA.4 and the original strain of the virus.
“We’ve validated the process several times over and continue to produce safe and effective vaccines against Covid-19,” a Pfizer spokeswoman said. Moderna said all current data indicates its shots are safe and effective.
Human trials for Moderna’s vaccine targeting the subvariants have started, and for the Pfizer-BioNTech vaccine are expected to start this month, the companies have said. Results won’t be available, however, before the U.S. government’s planned fall booster campaign.
“If we waited for clinical-trial results, thank you very much, we’d get them in the spring. It takes time to do clinical trials,” said William Schaffner, professor of medicine at Vanderbilt University Medical Center and a nonvoting liaison to the Centers for Disease Control and Prevention committee that will decide whether to recommend the shots, should the FDA sign off. “This is just an updating of the previous vaccine that we used.”
The retooled shots are similar to the original shots, but customized to fight the latest variants, much like keys that are nearly identical but have slightly different ridges and valleys, said John Grabenstein, director of scientific communications for Immunize.org, a nonprofit that seeks to boost immunization rates.
The similarities make it very reasonable for regulators to weigh the overwhelmingly safe track record of the original series when considering the new shots, he said.
The FDA has reviewed test results from a shot that Moderna modified to target an early version of Omicron as well as the ancestral strain of the coronavirus. The study found the shot generated a significant amount of antibodies in humans compared with the company’s currently available booster shot. That shot is now approved in the U.K.
The agency also looked at human data from Pfizer and BioNTech finding that their experimental shots, updated to target an earlier form of Omicron, also boosted antibody levels significantly. The companies have submitted one of those shots to the U.K., EU and Canada for authorization, Pfizer has said.
Such findings give the FDA confidence that the newest modified shots will also work well, said a person familiar with the agency’s deliberations.
“As we know from prior experience, strain changes can be made without affecting safety,” Dr. Califf said in a tweet.
Dr. Offit, however, said he would like to wait for clinical-trial data showing the shots are effective before asking people to take them.
“If you have some evidence that this is likely to be of value, sure,” he said. “But if you don’t have evidence, and you know that the current vaccine does offer protection against severe disease, I don’t think it’s fair to ask people to take risks.”