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Trump FDA overhauls COVID-19 vaccine approval to focus on older populations, high-risk individuals

The Food and Drug Administration is shifting its annual COVID-19 vaccine approval policies to focus on Americans older than age 65 and other «high-risk» individuals, while increasing the standard of evidence to approve COVID vaccines for low-risk individuals.
«The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,» FDA’s Center for Biologics Evaluation and Research chief, Vinay Prasad, and FDA Commissioner Martin Makary, wrote in the New England Journal of Medicine Tuesday. «These clinical trials will inform future directions for the FDA, but more important, they will provide information that is desperately craved by health care providers and the American people.»
Americans over the age of 65 and those considered at high-risk of contracting the virus will be able to receive an annual COVID-19 vaccine this fall, the essay outlined, while vaccines for low-risk Americans will likely face stricter scientific analysis before they are made available to the public. The FDA estimated that about «100 million to 200 million Americans» older than age 65 or considered at high-risk will still have access to vaccines.
Prasad and Makary said in their essay that the U.S. will move away from a «one-size-fits-all» paradigm that promoted COVID-19 vaccines for the vast majority of Americans, stretching from children to the elderly. The shift, they said, will bring America’s policies more in line with guidelines in European nations.
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Dr. Vinay Prasad and Dr. Marty Makary said in their essay that the U.S. will move away from a «one-size-fits-all» paradigm that promoted COVID-19 vaccines for the vast majority of Americans. (Getty Images)
«While all other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe Covid-19, the United States has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of 6 months,» the health leaders wrote in the New England Journal.
«The U.S. policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations,» they wrote. «We reject this view.»
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President Donald Trump and Health and Human Services Secretary Robert F. Kennedy Jr. (Anna Moneymaker/Getty Images)
The FDA’s policy shift will include requiring vaccine manufacturers to gather clinical trial data to justify rolling out new COVID-19 vaccines for Americans at low risk of contracting the virus.
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Prasad and Makary held a roundtable discussion on the framework outlined in their medical essay Tuesday afternoon to walk Americans through the policy shift. Prasad explained that health officials under the Trump administration are taking into account that Americans have balked at the FDA’s guidance under the Biden administration to receive multiple booster shots, while other Americans demand access to the vaccines.
«We have to admit to ourselves that America is deeply divided on the policy issue of repeat COVID 19 vaccine doses or boosters,» he said. «There are some Americans out there who are worried that the FDA has not fully documented and interrogated the safety harms of these products, and they are categorically opposed to these products. There are also some Americans we also have to recognize, who are desperate for additional protection, and they demand these products. But the truth is that most doctors and most of the public are entirely uncertain, and that is reflected in low vaccine uptake of these products.»

Americans’ trust in the scientific community has cratered since the COVID-19 pandemic, Dr. Vinay Prasad and Dr. Marty Makary noted. (AP Photo, File)
The pair added during the roundtable that Americans’ trust in the scientific community has cratered since the pandemic.
«Survey after survey shows trust in institutions like the FDA and scientists in general, it’s rock bottom,» Prasad said during the roundtable. «I mean, we have lower trust than Congress, and that’s saying something, you know. And we need to rebuild that trust. And part of rebuilding that trust is having conversations like this, writing articles like we’ve done in the New England Journal, and having a common-sense evidence-based framework for rebuilding that trust.»
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The pair cited in their article in the New England Journal that «public trust in vaccination in general has declined,» including for «vital immunization programs such as that for measles–mumps–rubella (MMR) vaccination, which has been clearly established as safe and highly effective.»
Coronavirus,Vaccine,Health,Senior Health,Donald Trump
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Trump’s ‘big, beautiful bill’ faces Republican family feud as Senate reveals its final text

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Senate Republicans unveiled their long-awaited version of President Donald Trump’s «big, beautiful bill,» but its survival is not guaranteed.
Senate Budget Committee Chair Lindsey Graham, R-S.C., revealed the stitched-together text of the colossal bill late Firday night.
The final product from the upper chamber is the culmination of a roughly month-long sprint to take the House GOP’s version of the bill and mold and change it. The colossal package includes separate pieces and parts from 10 Senate committees. With the introduction of the bill, a simple procedural hurdle must be passed in order to begin the countdown to final passage.
When that comes remains an open question. Senate Republicans left their daily lunch on Friday under the assumption that a vote could be teed up as early as noon on Saturday.
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President Donald Trump on June 18, 2025. (BRENDAN SMIALOWSKI/AFP via Getty Images)
Sen. John Kennedy, R-La., told Fox News Digital that he had «strongly encouraged» Senate Majority Leader John Thune, R-S.D., to put the bill on the floor for a vote Saturday afternoon.
«If you’re unhappy with that, you’re welcome to fill out a hurt feelings report, and we will review it carefully later,» Kennedy said. «But in the meantime, it’s time to start voting.»
But Senate Republicans’ desire to impose their will on the package and make changes to already divisive policy tweaks in the House GOP’s offering could doom the bill and derail Thune’s ambitious timeline to get it on Trump’s desk by the July 4 deadline.
However, Thune has remained firm that lawmakers would stay on course and deliver the bill to Trump by Independence Day.
When asked if he had the vote to move the package forward, Thune said «we’ll find out tomorrow.»
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But it wasn’t just lawmakers who nearly derailed the bill. The Senate parliamentarian, the true final arbiter of the bill, ruled that numerous GOP-authored provisions did not pass muster with Senate rules.
Any item in the «big, beautiful bill» must comport with the Byrd Rule, which governs the budget reconciliation process and allows for a party in power to ram legislation through the Senate while skirting the 60-vote filibuster threshold.

Senate Majority Leader John Thune speaks during a news conference following the weekly Senate Republican policy luncheon at the U.S. Capitol on June 17, 2025, in Washington. (Getty Images)
That sent lawmakers back to the drawing board on a slew of policy tweaks, including the Senate’s changes to the Medicaid provider tax rate, cost-sharing for food benefits and others.
Republican leaders, the White House and disparate factions within the Senate and House GOP have been meeting to find middle ground on other pain points, like tweaking the caps on state and local tax (SALT) deductions.
While the controversial Medicaid provider tax rate change remained largely the same, a $25 billion rural hospital stabilization fund was included in the bill to help attract possible holdouts that have raised concerns that the rate change would shutter rural hospitals throughout the country.
On the SALT front, there appeared to be a breakthrough on Friday. A source told Fox News that the White House and House were on board with a new plan that would keep the $40,000 cap from the House’s bill and have it reduced back down to $10,000 after five years.
But Senate Republicans are the ones that must accept it at this stage. Sen. Markwayne Mullin, R-Okla., has acted as the mediator in those negotiations, and said that he was unsure if any of his colleagues «love it.»
«But I think, as I’ve said before, I want to make sure we have enough that people can vote for than to vote against,» he said.
Still, a laundry list of other pocket issues and concerns over just how deep spending cuts in the bill go have conservatives and moderates in the House GOP and Senate pounding their chests and vowing to vote against the bill.
Republican leaders remain adamant that they will finish the mammoth package and are gambling that some lawmakers standing against the bill will buckle under the pressure from the White House and the desire to leave Washington for a short break.
Once a motion to proceed is passed, which only requires a simple majority, then begins 20 hours of debate evenly divided between both sides of the aisle.
‘BABY STEPS’: LEADER THUNE DETAILS HIS WORK TO CORRAL REPUBLICANS BEHIND TRUMP’S LEGISLATIVE VISION

House Speaker Mike Johnson speaks during a news conference at the U.S. Capitol Building on April 1, 2025, in Washington. (Anna Moneymaker/Getty Images)
Democratic lawmakers are expected to spend the entirety of their 10 allotted hours, while Republicans will likely clock in well below their limit. From there starts the «vote-a-rama» process, when lawmakers can submit a near-endless number of amendments to the bill. Democrats will likely try to extract as much pain as possible with messaging amendments that won’t actually pass but will add more and more time to the process.
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Once that is complete, lawmakers will move to a final vote. If successful, the «big, beautiful bill» will again make its way back to the House, where House Speaker Mike Johnson, R-La., will again have to corral dissidents to support the legislation. It barely advanced last month, squeaking by on a one-vote margin.
Treasury Secretary Scott Bessent hammered on the importance of passing Trump’s bill on time. He met with Senate Republicans during their closed-door lunch and spread the message that advancing the colossal tax package would go a long way to giving businesses more certainty in the wake of the president’s tariffs.
«We need certainty,» he said. «With so much uncertainty, and having the bill on the president’s desk by July 4 will give us great tax certainty, and I believe, accelerate the economy in the third quarter of the year.»
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Un hidrogel con cianobacterias podría ser una solución para combatir el cambio climático

Un material puede hacer que las paredes de un edificio ayuden a limpiar el aire que las rodea y a mitigar el problema del cambio climático. Eso no es magia: es el resultado de un avance científico real realizado en una universidad pública de Suiza.
Fue realizado por investigadores de ETH Zurich, la institución que fue fundada en 1855 y tuvo como alumnos al físico Albert Einstein y a otros 21 ganadores de Premios Nobel. Incluyeron cianobacterias dentro de un hidrogel, que es un polímero inerte, y obtuvieron un material vivo artificial.
El nuevo material es capaz de capturar dióxido de carbono (CO₂) de manera eficaz, mientras genera minerales que lo almacenan de forma estable. Los resultados fueron publicados en la revista Nature Communications.

Significa que, además de transformar el CO2 en biomasa a través de la fotosíntesis, las cianobacterias inducen la formación de minerales y así se consigue un almacenamiento mucho más duradero y seguro del carbono capturado en el propio material.
Consideran que la innovación podría ofrecer una solución escalable y sostenible que elimina el CO₂ de la atmósfera al emplear procesos naturales.

El dióxido de carbono siempre ha estado presente en la atmósfera. Es parte natural del aire que se respira y del ciclo del carbono del planeta.
Pero su presencia aumentó por actividades humanas como la quema de combustibles fósiles (petróleo, gas, carbón) y la deforestación.
Este exceso de CO₂ atrapa calor en la atmósfera y eso condujo a que las temperaturas globales suban, los glaciares se derritan, los océanos se calienten, entre otros impactos.
El CO₂ no es “malo” en sí mismo: las plantas lo necesitan para hacer fotosíntesis. Pero en exceso desequilibra el sistema.
Científicos de todo el mundo buscan formas efectivas de capturar ese CO₂ para defender la salud del planeta.

La mayoría de los métodos conocidos hasta ahora son costosos, requieren mucha energía o no consiguen guardar el carbono durante mucho tiempo.
Algunos grupos han probado con técnicas químicas y otros con organismos vivos como plantas y algas.
Pero, hasta este avance, no se había combinado con éxito un material inerte y un organismo vivo que sigue activo dentro del hidrogel y tiene capacidad de almacenar carbono en formas estables.
El equipo de ETH Zurich decidió enfrentar el desafío de hacer algo muy diferente.

Para fabricar el nuevo material, el equipo usó un hidrogel, que es como una esponja blanda hecha con polímeros. Este gel deja pasar agua, luz y CO₂.
Dentro del hidrogel colocaron millones de cianobacterias, microorganismos que viven en la Tierra desde hace millones de años y pueden hacer fotosíntesis.
Las cianobacterias usan la luz solar para transformar el CO₂ del aire en alimento y oxígeno. También producen una reacción especial: su actividad provoca la formación de minerales sólidos, como la cal, que guarda el CO₂ por mucho tiempo dentro del gel.
El equipo utilizó impresión 3D para dar forma al material y optimizar la entrada de luz, agua y nutrientes. Así crearon piezas y bloques que funcionan bien para proyectos grandes.

Dalia Dranseike, quien fue primera autora del trabajo junto con Yifan Cui, explicó: “El material tiene estructuras que dejan pasar luz y distribuyen el líquido con nutrientes gracias a la capilaridad”.
El material logró resultados increíbles: en el laboratorio, pudo atrapar CO₂ de forma constante durante 400 días.
Cada gramo retuvo 26 miligramos de CO₂, y superó a otros métodos como el llamado “hormigón reciclado”. Los minerales que se forman en su interior vuelven el material más fuerte y resistente.
Las posibles aplicaciones van más allá de los experimentos. Los investigadores imaginan que el nuevo material se podría usar en edificios, fachadas y objetos urbanos para limpiar el aire y ayudar a combatir el cambio climático.

Después de los éxitos en el laboratorio, el equipo de ETH Zurich llevó su material a exposiciones internacionales de arquitectura. Andrea Shin Ling, arquitecta y miembro del equipo, fue clave en este paso.
En la Bienal de Arquitectura de Venecia montaron troncos de hasta tres metros de alto, formados por el material vivo que contiene cianobacterias. Cada tronco puede capturar 18 kilos de CO₂ por año, similar a lo que absorbe un pino adulto.
La arquitecta contó que el mayor desafío fue escalar el proceso, ya que fabricar piezas grandes es muy diferente al trabajo de laboratorio.
En tanto, en la Trienal de Milán, cubrieron tejas de madera con el hidrogel y las cianobacterias. Con el tiempo, formaron una “piel” verde sobre la madera, un signo claro de que las bacterias seguían vivas y activas capturando CO₂.
Observar el cambio de color y el trabajo de las cianobacterias resultó emocionante para el equipo.

En diálogo con Infobae, la doctora Graciela Salerno, investigadora superior del Conicet en cianobacterias y biotecnología, profesora emérita de la Universidad Nacional de Mar del Plata y vicepresidente del Comité Ejecutivo de la Fundación para Investigaciones Biológicas Aplicadas (FIBA), comentó: “Se busca desde hace varias décadas en diferentes laboratorios, el desarrollo de métodos de secuestro de dióxido de carbono a través de materiales fotosintéticos”.

Tras leer el estudio publicado en Nature Communications, la doctora Salerno, quien no participó en la investigación, opinó que los investigadores de Suiza “le han dado una vuelta interesante y desarrollaron una innovación que combina el poder de las cianobacterias con ingeniería de materiales”.
Además, la científica expresó: “Si bien falta aún escalar la producción y evaluar su implementación práctica, el hidrogel podría ser una estrategia más para combatir al cambio climático. Por supuesto, también se necesita que se reduzcan las emisiones de gases de efecto de invernadero para no seguir agravando el problema”.
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