FDA Covid booster approval standards

Stricter approval requirements for healthy Americans were set by the Food and Drug Administration on Tuesday in its new regulatory guidance for upcoming Covid-19 vaccination boosters.

A pricey new requirement for pharmaceutical companies that might limit who receives new vaccines annually, the FDA stated that it wants to see new clinical trials demonstrating that Covid injections are still safe and effective before licensing them for healthy adults and children. In the past, the FDA usually authorized new Covid vaccines for every American annually based on straightforward testing that shown they produced a sufficiently potent antibody response.

According to a report released Tuesday in the New England Journal of Medicine, the FDA suggested various standards of proof for approval depending on patients’ likelihood of developing serious Covid-related illness. The authors of the study are Vinay Prasad, a vocal opponent of the pharmaceutical business who was selected to head the FDA’s vaccines section, and Commissioner Marty Makary.

According to the FDA’s document, “the new Covid-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science.” “The FDA will authorize vaccines for high-risk individuals while simultaneously requiring solid, gold-standard data on low-risk individuals.”

The new guidelines coincide with a reorganization of the country’s health agencies and U.S. immunization policy by Health and Human Services Secretary Robert F. Kennedy Jr., a well-known vaccine skeptic.

The FDA stated that it will accept immunogenicity data, which demonstrates that a vaccine elicits a robust immune response, as sufficient evidence that the advantages of a shot outweigh the risks for adults 65 and older and for individuals as young as 6 months who have specific underlying medical problems. According to the FDA, between 100 and 200 million Americans suffer from mental health disorders like depression and obesity, which increase their risk of developing serious illnesses.

However, the FDA intends to demand more robust proof for vaccines from randomized, controlled trials for healthy individuals aged 6 months to 64 who do not have risk factors. Before fully approving a vaccination, the agency stated that these trials must demonstrate real clinical results, such fewer hospitalizations or infections.

Makary and Prasad wrote, “Our policy also balances the need for evidence.” We just don’t know if a 52-year-old lady in good health with a normal body mass index who has had COVID-19 three times and has already received six doses of the vaccination will benefit from the seventh dose.

The FDA stated that as part of their post-marketing commitment for the vaccine, it will encourage manufacturers to carry out randomized, controlled clinical trials in healthy adults after approving a Covid vaccination for high-risk individuals.

Makary and Prasad contended that the country’s “one-size-fits-all” approach to Covid vaccine policy, which suggests yearly vaccinations for all Americans older than six months, is out of date and no longer consistent with other nations. They claimed that all other high-income countries only prescribe vaccines for elderly persons or people who are at a high risk of developing a serious illness from COVID-19.

According to them, the advantages of receiving more vaccinations are “uncertain,” especially for low-risk individuals who have already gained some immunity from prior immunizations, illnesses, or both. Makary and Prasad cited statistics from the Centers for Disease Control and Prevention showing declining annual Covid booster immunization rates in the United States to support their claim that many Americans and healthcare professionals “remain unconvinced” of that benefit.

Less than 25% of Americans, including less than 10% of children and less than 50% of those over 75, had received a Covid-19 vaccination during the last two seasons, according to CDC data they quoted. Citing CDC data, they stated that less than one-third of healthcare workers received updated Covid boosters during the 2023–2024 season.

Additionally, they proposed that the annual broad Covid vaccine recommendations have played a role in the erosion of vaccination confidence, including in the measles, mumps, and rubella vaccine. MMR vaccines were nevertheless described by Makary and Prasad as “clearly established as safe and highly effective.”

At a virtual town hall on Tuesday at 1 p.m. ET, Makary and Prasad will go into additional detail about the new structure.

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Xiaomi YU7 SUV launch

This Thursday, Xiaomi (HKG: 1810, OTCMKTS: XIACY) will formally introduce the YU7, a car that could revolutionize the electric SUV (sport utility vehicle) market in China.

The first SUV, the Xiaomi YU7, will be unveiled during Xiaomi’s key new product launch event on May 22 at 7 p.m. Beijing time, according to a Weibo post made today by Xiaomi EV, the company’s electric vehicle (EV) division.

“Witness together, a new beginning for Xiaomi’s 15th anniversary,” said Xiaomi EV. The Xring O1, Xiaomi’s first mobile SoC (system on a chip), the Xiaomi 15S Pro smartphone, and the Xiaomi 7 Ultra tablet will also be part of the debut in addition to the YU7.

On March 28, 2024, Xiaomi formally unveiled the SU7, an electric automobile that competes with Tesla’s (NASDAQ: TSLA) Model 3.

Xiaomi’s electric vehicle, the SU7 Ultra, which is based on the standard SU7 and has a maximum horsepower of 1,548 Ps, was introduced on February 27.

Xiaomi, a latecomer to the Chinese EV industry, has achieved remarkable success in this fiercely competitive arena.

On May 1, Xiaomi EV declared that it had shipped over 28,000 units in April, the seventh consecutive month that it had supplied over 20,000 units.

Xiaomi EV revealed last December that the YU7, a rival to the Tesla Model Y, will be its second model and would go on sale in June or July 2025.

According to a regulatory filing at the time, the YU7 had a wheelbase of 3,000 mm and dimensions of 4,999 mm in length, 1,996 mm in width, and 1,600 mm in height.

In contrast, the revised Model Y has a wheelbase of 2,890 mm and dimensions of 4,797 mm in length, 1,920 mm in width, and 1,624 mm in height.

It’s important to remember that the Xiaomi EV has been under a lot of public pressure in the last two months because of the late March SU7 crash that claimed three lives.

Furthermore, the company is under additional pressure because over the past month, numerous complaints regarding the Xiaomi SU7’s quality have surfaced on Chinese social media.

Xiaomi EV sales appear to have been impacted by these. According to data provided by CnEVPost, insurance registrations for Xiaomi EV fell 8.96 percent to 5,180 in the week ending May 11 from 5,690 the week before. This was the third consecutive week of declines.

U.S. debt downgrade

Early Monday saw a decline in stock futures as investors reacted to Moody’s downgrading the U.S. credit rating.

Dow Jones Industrial Average-linked futures fell 337 points, or 0.79%. Nasdaq 100 futures fell 1.19%, while S&P 500 futures declined 0.97%.

Moody’s downgraded the nation’s rating from Aaa to Aa1 on Friday, bringing the agency into line with its peers. The firm mentioned the consequences of rolling over current U.S. loans during a time of high borrowing costs, as well as the funding difficulties associated with the federal government’s widening budget deficit.

At a time when President Donald Trump’s evolving tariff policy is already exerting pressure on the economy, the debt downgrade may cause bond prices and yields to rise.

Regarding the U.S. rating adjustment, Peter Boockvar, chief investment officer at Bleakley Financial Group, stated that “the fundamental factor of less foreign demand for them and the growing size of the pile of debt that needs to be constantly refinanced is not going to change.” In the sense that a major rating agency is pointing out that the United States has burdensome debts and deficits, Moody’s downgrading “is symbolic.”

Following a successful week on Wall Street, when investors applauded the White House’s agreement with China to temporarily lower duties, the downgrade was announced. Following the announcement of Trump’s initial plan for high and wide import levies last month, the accord was viewed as a significant step forward for international commerce.

With a gain of over 7%, the technology-heavy Nasdaq Composite took the lead. The broad S&P 500 posted a five-day winning streak after jumping more than 5%.

Last week, the blue-chip Dow had a more than 3% rally. The 30-stock average entered positive territory for 2025 with a gain of more over 300 points on Friday.

Investors will keep an eye on statements made by U.S. central bank officials throughout the day on Monday, including those of Dallas Fed President Lorie Logan, New York Fed President John Williams, and Atlanta Federal Reserve President Raphael Bostic. Data on leading indicators is expected in the morning.

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