Day: August 9, 2022

U.S. health officials on Tuesday authorized a plan to stretch the nation’s limited supply of monkeypox vaccine by giving people just one-fifth the usual dose, citing research suggesting the reduced amount is about as effective. 

The so-called dose-sparing approach also calls for administering the Jynneos vaccine with an injection just under the skin rather than into deeper tissue — a practice that may rev up the immune system better. Recipients would still get two shots spaced four weeks apart. 

The unusual step is a stark acknowledgment that the U.S. currently lacks the supplies needed to vaccinate everyone seeking protection from the rapidly spreading virus. 

That includes 1.6 million to 1.7 million Americans considered by federal officials to be at highest risk from the disease, primarily men with HIV or men who have a higher risk of contracting it. Vaccinating that group would require more than 3.2 million shots. 

White House officials said the new policy would immediately multiply the 440,000 currently available full doses into more than 2 million smaller doses. 

“It’s safe, it’s effective, and it will significantly scale the volume of vaccine doses available for communities across the country,” Robert Fenton, the White House’s monkeypox response coordinator, told reporters. 

The Biden administration declared monkeypox a public health emergency last week in an effort to slow the outbreak that has infected more than 8,900 Americans. 

The FDA authorized the approach for adults 18 and older who are at high risk of monkeypox infection. Younger people can also get the vaccine if they are deemed high risk, though they should receive the traditional injection, the agency said. 

FDA officials stressed that the second dose is critical to ensuring protection. 

“We feel pretty strongly that the two doses are necessary because, in part, we don’t have any evidence that three, six, eight months later people will be adequately protected by a single dose,” said Dr. Peter Marks, the FDA’s vaccine chief. 

Regulators pointed to a 2015 study showing that inoculation with one-fifth of the traditional two-dose vaccine generated a robust immune-system response comparable to that of the full dose. About 94% of people receiving the smaller dose had adequate levels of virus-fighting antibodies, compared with 98% of those receiving the full dose, according to the study funded by the National Institutes of Health. 

The NIH is planning an additional trial of the technique. And Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said her agency is starting to track real-world vaccine effectiveness in U.S. communities. 

But some experts and advocates worried that with little data to support the policy, it could backfire if it reduces vaccine effectiveness. 

“We have grave concerns about the limited amount of research that has been done on this dose and administration method, and we fear it will give people a false sense of confidence that they are protected,” said David Harvey of the National Coalition of STD Directors in a statement. 

The smaller doses require a different type of injection that penetrates only the top layer of skin, rather than the lower layer between the skin and muscle. That’s a less common technique that may require extra training for some health practitioners.  

“Intradermal administration is certainly something that has been used for other vaccines, including the smallpox vaccine, which was administered to hundreds of millions of people during the 20th century,” said Anne Rimoin, director of UCLA’s Center for Global and Immigrant Health. 

The shallower injection is thought to help stimulate the immune system because the skin contains numerous immunity cells that target outside invaders. 

Rationing vaccine doses is common in Africa and other parts of the world with limited health resources. In recent years the World Health Organization has endorsed the strategy to address outbreaks of yellow fever, polio and other diseases. 

Both the U.K. and Canada have adopted a single-dose vaccine strategy prioritizing people who face the highest risk from monkeypox. And health departments in several large U.S. cities adopted a similar strategy amid limited supplies, including New York, San Francisco and Washington. 

Officials said Tuesday that anyone who previously received a full first dose can get the smaller amount for their second dose. 

U.S. officials have shipped more than 625,000 full vaccine doses to state and local health departments.  

The Biden administration has come under fire for not quickly marshaling millions more doses from the strategic national stockpile.  

The FDA approved the Jynneos vaccine in 2019 to prevent smallpox and monkeypox based, in part, on studies in monkeys.  

Additional human studies showed people who received Jynneos had an immune response similar to those who received an older smallpox vaccine. But Jynneos hasn’t been tested in humans with either monkeypox or its relative smallpox, which was eradicated decades ago. 

 
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The World Meteorological Organization or WMO reports the month of July was one of the three warmest on record globally. This, despite a weak La Nina event, which is supposed to have a cooling influence.

Meteorologists warn the heatwave that swept through large parts of Europe last month is set to continue in August. They note July was drier than average in much of Europe, badly affecting local economies and agriculture, as well as increasing the risk of wildfires.

WMO Spokeswoman Clare Nullis says Britain’s Met Office has issued another advisory warning of a heat buildup throughout this week. However, she says temperatures are not expected to reach the extreme, record-setting temperatures of more than 40 degrees Celsius seen in July.

“But it is well above average. Temperatures in France this week, well above average. In Switzerland, many parts of Switzerland well above average. And as I said, continuing the trend that we saw in July, Spain saw its hottest ever month in July. So, not just the hottest July but the hottest ever month on record.”

Nullis says Europe and other parts of the world will have to get used to and adapt to the kind of heatwaves WMO’s Secretary-General Petteri Taalas calls “the new normal.”

While Europe was sweltering under extreme heat in July, WMO reports Antarctic Sea ice reached its lowest July level on record. This follows a record low Sea ice level in June. While Europe saw a lot of heat in July, Nullis notes big chunks of the Antarctic did as well.

“It is important to bear in mind there is quite a big sort of monthly and year-to-year variability in Antarctica. So, the fact that it was the lowest on record in June and in July does not mean necessarily that this is a long-term irreversible trend.”

WMO reports the long-lasting drought in parts of Europe also is set to continue. It warns below-normal precipitation in many parts of Europe will cause or worsen drought conditions and likely trigger more forest fires.
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U.S. President Joe Biden has signed the CHIPS and Science Act, which aims to boost U.S. competitiveness against China by allocating billions of dollars toward domestic semiconductor manufacturing and scientific research.

“The United States must lead the world in the production of these advanced chips. This law will do exactly that,” Biden said in remarks during the signing ceremony Tuesday. The president is recovering from COVID-19 and coughed repeatedly during his remarks.

He called the bipartisan legislation a “once in a generation investment” in the country and said it will create good jobs, grow the economy and protect U.S. national security.

Biden noted stiff competition with China in the chips industry. “It’s no wonder the Chinese Communist Party actively lobbied U.S. business against this bill,” he remarked.

Biden was joined on stage for the event by House Speaker Nancy Pelosi, Senate Majority Leader Charles Schumer, Commerce Secretary Gina Raimondo, and Joshua Aviv, CEO of Spark Charge, an electric vehicle charging network.

Schumer called the legislation the “largest investment in manufacturing science and innovation in decades” and thanked Republican Senator Todd Young for his partnership for over three years working on semiconductor-related legislation, beginning with what was then called the Endless Frontier Act.

The proposed act went through various iterations before it was passed as the $280 billion CHIPS and Science Act on a 243-187 vote in the House of Representatives and a 64-33 vote in the Senate in July.

Last year, a semiconductor shortage affected the supply of automobiles, electronic appliances and other goods, causing higher inflation globally and pummeling Biden’s public approval rating among American voters.

Catching up in the chips race

The CHIPS Act includes $52 billion in incentives for domestic semiconductor production and research, as well as an investment tax credit for semiconductor manufacturing. Advocates say it will allow the U.S. to catch up in the global semiconductor manufacturing race currently dominated by China, Taiwan and South Korea.

Following the passage of the bill, the White House noted that Micron, a leading U.S. chip manufacturer, will announce a $40 billion plan to boost domestic chip production while Qualcomm and GlobalFoundries will unveil a $4.2 billion expansion of a chip plant in New York.

The U.S. share of global semiconductor manufacturing capacity has decreased from 37% in 1990 to 12% today, largely because other governments have offered manufacturing incentives and invested in research to strengthen domestic chipmaking capabilities, according to a state of the industry report by the Semiconductor Industry Association.

Now China accounts for 24% of the world’s semiconductor production, followed by Taiwan at 21%, South Korea at 19% and Japan at 13%, the report said.

The CHIPS Act also includes $4.2 billion to fund defense initiatives and the U.S. mobile broadband market, particularly efforts to promote non-Chinese 5G equipment manufacturing.

Broadly, the legislation lays out a strategy for Washington as it aims for global technological and economic dominance – gaining production autonomy by leveraging allies, including South Korea and Japan and eliminating political dependencies on the global semiconductor supply chain.

That strategy puts the U.S. on a collision course with China, which also aims to be the global leader in semiconductors. In 2015, Beijing launched the Made in China 2025 project, which aimed to increase chip production from less than 10% of global demand at the time to 40% in 2020 and 70% in 2025.

The Taiwan factor

Taiwan — a self-governed island that Beijing claims to be its breakaway province — is the main producer of the world’s most high-tech chips. It lies at the heart of the semiconductor showdown, the latest battlefront in the increasingly tense U.S.-China strategic rivalry.

Taiwan accounts for 92% of the global production of 10 nm or smaller semiconductors, essentially creating what some observers have characterized as a “silicon shield” that ensures American support in the event of a Chinese attack, as well as a deterrence against such a move.

In a visit to Taipei that angered Beijing earlier this month, U.S. House Speaker Nancy Pelosi met with Mark Liu, chairman of Taiwan Semiconductor Manufacturing Co., the world’s biggest chipmaker.

Pelosi delivered all but one Democratic vote in the House of Representatives for the CHIPS Act. “Mr. President with the stroke of your pen, America declares our economic independence,” she said in her remarks Tuesday. “We strengthen our national security, and we enhance our family’s financial future.”

Following Pelosi’s Taiwan visit, Beijing halted key communication channels with Washington and conducted live-fire military drills, raining Dongfeng ballistic missiles into the waters near Taiwan’s eastern, southern, and northern coasts.

While most experts don’t believe a war over Taiwan is imminent, many fear a conflict there would disrupt semiconductor production and have disastrous effects on global manufacturing.
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