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Pfizer to seek FDA approval for Lyme disease vaccine candidate despite trial miss
Thomas Fuller | Nurphoto | Getty Images
Pfizer on Monday said it will seek regulatory approval for a Lyme disease vaccine candidate despite the shot failing a late-stage trial.
Pfizer said the vaccine missed the trial’s statistical goal because not enough people in the study contracted Lyme disease to be confident in the results. Still, the company said the shot reduced the rate of infection by more than 70% in people who received the vaccine versus placebo, efficacy the company thinks is strong enough to take to regulators.
“The efficacy shown in the VALOR study of more than 70% is highly encouraging and creates confidence in the vaccine’s potential to protect against this disease that can be debilitating,” Pfizer Chief Vaccines Officer Annaliesa Anderson said in a statement.
A vaccine for Lyme disease isn’t expected to become a best-seller for Pfizer, with the company’s partner Valneva estimating peak annual sales of $1 billion. Pfizer expects overall revenue of around $60 billion this year, with its Covid-19 vaccine representing more than $5 billion of that forecast.
But Pfizer had billed the Lyme vaccine results as one of its major catalysts this year, and it represented a chance to introduce the only human vaccine for Lyme disease.
Moving forward with a shot that technically failed a clinical trial under an administration that has preached stricter scrutiny for vaccines may prove risky for Pfizer, and it could serve as a litmus test for vaccine policy in the U.S.
Lyme disease is an illness caused by bacteria most commonly spread to humans from ticks. It can cause arthritis, muscle weakness and pain. About half a million Americans are diagnosed with or treated for Lyme disease every year, according to estimates from the Centers for Disease Control and Prevention.
Despite the disease’s prevalence, especially in the Northeast, there isn’t a vaccine for humans available. A company that would later become GSK introduced a shot called LYMErix in 1998 but pulled it only a few years later after public concerns about safety tanked demand. That experience hobbled development of Lyme vaccines for humans, though multiple companies now make them for dogs.
Pfizer and Valneva have faced their own setbacks. In 2023, the companies dropped about half of the participants in the Phase 3 trial because of quality concerns with third-party clinical trial site operator Care Access. The trial had initially enrolled about 18,000 people and after the cuts ended up with about 9,400.
The companies’ vaccine targets the outer surface protein A of the bacteria that cause Lyme disease. A vaccinated person creates antibodies that are passed to a tick and prevent the bacterium from being transferred from the tick to the human. The series involves three shots in the first year, then a booster dose the following year.
The companies said they didn’t observe any safety concerns in the trial.
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Trump Might Welcome Chinese Investment, but America Is Wary
A hallmark of President Trump’s second term has been his penchant for negotiating economic deals with countries that pledge to invest trillions of dollars in the United States
“It’s now pouring in from all parts of the world,” Mr. Trump said during a speech last fall in which he boasted of nearly $20 trillion of foreign investment.
The meetings this week between Mr. Trump and China’s leader, Xi Jinping, in Beijing are expected to include talks over purchases of American farm products and planes and the possibility of expanding access for American companies into China’s vast consumer market.
There has also been speculation that Mr. Trump and his advisers are seeking a major investment from China. But such a pledge could be complicated by deep distrust in the United States toward Chinese firms, which many workers blame for the hollowing out of American manufacturing.
Treasury Secretary Scott Bessent acknowledged the challenge in an interview on CNBC on Thursday, explaining that the United States and China were working to develop an investment board that would determine what sectors were acceptable for Chinese investment. That would essentially provide China with guidance on how to invest in the United States without its transactions being blocked by the Committee on Foreign Investment, an interagency group that reviews foreign investment and is led by Mr. Bessent.
“Look, there are plenty of things that the Chinese could invest in in the U.S.,” said Mr. Bessent, who is in Beijing with Mr. Trump.
Chinese investment in the United States has declined sharply in recent years amid tougher investment screening standards nationally and at the state level.
That sentiment could ultimately clash with Mr. Trump’s transactional instincts and his desire to return home with a big-ticket win.
“If Trump were to be committed to a major investment deal with China, there’s still a challenge of implementation,” said Kyle Jaros, an expert on U.S.-China ties at the University of Notre Dame. “It would take real follow-through to overcome a lot of the political and regulatory barriers that are in place right now.”
According to a report published last month by the research firm Rhodium Group, less than $3 billion of Chinese investment in the United States was announced in 2025. That was the lowest on record, with investment peaking at around $45 billion in 2016.
The United States has imposed tight restrictions on Chinese investment out of national security concerns, making it difficult for Chinese firms to build factories near military facilities. Some states also have enacted restrictions on Chinese purchases of real estate and farmland.
China’s clean energy technology, such as electric vehicles and batteries, has also faced challenges in the United States because of political backlash. There was a surge of Chinese investment in those sectors after clean energy and tax legislation was passed under the Biden administration in 2022, but according to Rhodium, more than half of those investments have been canceled, paused or delayed.
A $2.4 billion electric vehicle battery factory that the Chinese company Gotion was building in Michigan was canceled last year after the community there protested and mounted legal challenges to stop the project.
Other types of Chinese investment have also stirred controversy. That includes the recent purchase by Nongfu Spring, a Chinese bottled water company, of a warehouse in New Hampshire that it wants to turn into a bottling facility. The purchase was reviewed last year by the state’s attorney general.
After the inquiry found that there was no wrongdoing associated with the transaction, Gov. Kelly Ayotte of New Hampshire issued executive orders to block China, Russia and Iran from getting access to data or purchasing land or property in the state. “Foreign adversaries like China should not be doing business in New Hampshire,” said Ms. Ayotte, a Republican.
There continues to be deep skepticism within the U.S. automobile industry about competition from China. Last month, a group of American steel associations sent a letter to top Trump administration officials urging them to keep Chinese car manufacturers out of the United States.
“As representatives of our nation’s manufacturing sector, we urge you to ensure American competitiveness by not surrendering access to the U.S. auto market to the Chinese Communist Party,” they wrote. “Additionally, allowing Chinese companies and Chinese autos into the U.S. would create consequential, unacceptable national security risks.”
Agriculture also remains a contentious issue. The chairman of the House select committee on China, Representative John Moolenaar, a Republican from Michigan, introduced new legislation this month that would ban China from acquiring U.S. farmland.
“Food security is national security, and we cannot allow foreign adversaries like China to buy up American farmland near our most sensitive military and critical infrastructure sites,” Mr. Moolenaar said.
The bipartisan bill would create a requirement for the federal government to review Chinese deals involving ports and telecommunications infrastructure. It would also apply to purchases made by investors from Russia, Iran and North Korea
Michael Pillsbury, a China scholar who has served as an outside adviser to the Trump administration, said that the president’s advisers were concerned about Chinese investments in sensitive sectors such as semiconductors, artificial intelligence, biotechnology, aerospace and critical minerals. It has been a challenge, he said, to come up with a “white list” of sectors that could be considered safe.
“The red lines have moved back and forth as the nature of technology has changed,” Mr. Pillsbury said.
He added that while Mr. Trump is eager to announce a $1 trillion Chinese investment pledge, he is mindful not to incite political backlash.
“I think there’s been an effort by the administration to avoid getting into a fight with the China hawks,” Mr. Pillsbury added.
Ahead of Mr. Trump’s trip to China, a White House official downplayed the idea that the administration was seeking to create a new $1 trillion Chinese investment program. The White House continues to be focused on pushing China to increase its purchases of American farm goods, which it boycotted for much of last year when trade tensions flared.
Despite the anticipation of a Chinese investment pledge, the details and follow-through will be important.
While Mr. Trump has said that foreign investments have topped $20 trillion, according to the White House’s own investment tracker, U.S. and foreign investment pledges made during Mr. Trump’s second term total $10.6 trillion. Foreign leaders appear to have learned that they can win favor with Mr. Trump by promising whopping investment pledges that they might not fulfill.
“The devil is in the details,” said Philip Ludvigson, a partner in King & Spalding who specializes in national security risks and foreign investment, “about not only where the investment goes but also whether it happens at all.”
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