The new shot is expected to play a key role in the fight against coronavirus abroad.
Novavax Releases Clinical Trial Findings
The American biotech firm Novavax announced Monday that its COVID-19 vaccine was found to be highly effective in a large clinical trial.
According to a press release from the company, the study of nearly 30,000 people in the U.S. and Mexico showed that the two-shot vaccine was about 90% effective overall and 100% effective at protecting against moderate and severe disease, putting it on par with Moderna and Pfizer.
Notably, the company also said that the shot had 93% efficacy against some of the other concerning variants.
Pending regulatory approval, Novavax plans to manufacture 100 million doses by the end of the third quarter and 150 million by the end of the year.
Monday’s announcement officially paves the way for a fourth American-made vaccine in the global fight against the coronavirus — and one that is easier to store and transport than its competitors.
But unlike Moderna, Pfizer, and Johnson & Johnson, this latest vaccine will likely have a more immediate impact on efforts abroad rather than in the U.S.
Expected Global Impact
The U.S. currently has enough shots to go around and demand has dropped significantly.
As a result, while Novavax has said it will seek approval from the Food and Drug Administration as well as regulators in the E.U. and the U.K. by the end of the summer, it remains unclear if the FDA would grant the shot the same emergency authorization as the three others.
Instead, it could be required to go through standard licensing procedures, which would take considerably longer.
Novavax, however, appears prepared for this possibility. While speaking to reporters Monday, CEO Stanley Erck said the U.S. process may take longer than anywhere else.
He also said he anticipates the jab will have its largest impact in other countries through the World Health Organization’s Covax initiative, to which Novavax has already pledged 1.1 billion doses.
“Many of our first doses will go to … low- and middle-income countries, and that was the goal to begin with,” Erck said.
Still, the new vaccine could also play a key role in the U.S., which had already pre-ordered 110 doses, because the shot relies on a different kind of protein-based technology than the other three American-made jabs.
“The protein-based technology used in the Novavax vaccine may do a particularly good job at amplifying protection, even if people have previously been vaccinated with a different formulation,” The New York Times explains. “Many vaccine experts expect that, with waning immunity and emerging variants, the country will need booster shots at some point.”
See what others are saying: (The Washington Post) (Axios) (The New York Times)
FDA Authorizes Moderna and J&J COVID Vaccine Boosters, Approves Mix-and-Match Doses
The approval will allow at-risk Americans who received Pfizer and Moderna vaccines to get any booster six months after their initial series and all Johnson & Johnson recipients 18 and older to do the same two months after their single-shot dose.
New FDA Authorization
The U.S. Food and Drug Administration (FDA) on Wednesday authorized boosters shots of Moderna and Johnson & Johnson COVID-19 vaccines and approved a mix-and-match strategy that will allow people who got one company’s shot to get a booster from a different maker.
The decision paves the way for millions of more at-risk Americans to get extra protection, and not just certain Pfizer recipients as previously approved by the FDA.
Under the authorization, people who received Moderna or Pfizer can get any one of the three booster shots six months after completing their initial series if they are 65 and older, at high risk of severe COVID, or face increased exposure because of their work.
Meanwhile, all J&J recipients 18 and older can get any of the approved vaccines two months after they received the one-shot jab.
Hazy Recommendations, For Now
Notably, the FDA did not recommend a certain combination of vaccines, nor did the agency say whether or not it would be more effective for people to stick with their original vaccine maker for their booster.
The new authorizations draw on a study from the National Institutes of Health (NIH), which found that there are no safety concerns with mixing boosters and that vaccine combinations were at least as effective in stimulating antibodies as matched vaccines.
In the case of J&J recipients, the NIH found that people actually had a higher boost from mixing either Moderna or Pfizer boosters.
However, some of the scientists who worked on the study said it should not be used to recommend one combination over another because the research was limited.
The Centers for Disease Control and Prevention (CDC), which determines vaccine recommendations, could issue more guidance on when and whether people should switch vaccine makers for their booster shots.
An advisory panel for the agency is meeting Thursday to discuss the new FDA authorizations and recommendations.
Once the panel makes its decision, the CDC director has the final say on the guidelines. If the agency agrees with the FDA’s decisions, the booster shots could be rolled out as soon as this weekend.
See what others are saying: (The New York Times) (NPR) (The Washington Post)
Paris Hilton Urges Lawmakers To Crack Down on Abusive Teen Treatment Facilities
The heiress alleges that she was a victim of abuse in these types of centers for two years and wants to ensure that no child suffers through the same experience.
Paris Hilton Details Abuse Within “Troubled Teen Industry”
Socialite and entrepreneur Paris Hilton spoke outside of the U.S. Capitol on Wednesday to support the Accountability for Congregate Care Act, which is set to be introduced in the near future.
Hilton joined Rep. Ro Khanna (D-CA), Rep. Adam Schiff (D-CA), Rep. Rosa DeLauro (D-Conn.), and Sen. Jeff Merkley (D-Ore.) to advocate for the legislation, which aims to create a “bill of rights” for children in treatment and behavioral centers.
The heiress has alleged that she spent two of her teenage years in these types of facilities and was subject to rampant abuse. She is far from alone.
During a press conference, Hilton said that one night when she was 16, she woke up to two large men in her bedroom forcing her out of her house. She said she screamed for help because she thought she was being kidnapped, but her parents watched as she was taken away to a “troubled teen” program.
“Like countless other parents of teens, my parents had searched for solutions to my rebellious behavior,” she explained in an op-ed for The Washington Post this week. “Unfortunately, they fell for the misleading marketing of the ‘troubled teen industry’ — therapeutic boarding schools, military-style boot camps, juvenile justice facilities, behavior modification programs and other facilities that generate roughly $50 billion annually in part by pitching ‘tough love’ as the answer to problematic behavior.”
Hilton said she was sent to four different facilities where she was “physically and psychologically abused.”
“I was strangled, slapped across the face, watched in the shower by male staff, called vulgar names, forced to take medication without a diagnosis, not given a proper education, thrown into solitary confinement in a room covered in scratch marks and smeared in blood and so much more,” she explained during the press conference.
“At Provo Canyon School in Utah, I was given clothes with a number on the tag. I was no longer me, I was only number 127,” she continued. “I was forced to stay indoors for 11 months straight, no sunlight, no fresh air. These were considered privileges.”
Goals of the Accountability for Congregate Care Act
Hilton claims that a lack of transparency and accountability has allowed this structure of abuse to thrive for decades. In some cases, she said it has taken children’s lives. Now, she wants Congress and President Joe Biden to act.
“This bill creates an urgently needed bill of rights to ensure that every child placed into congregate care facilities is provided a safe and humane environment,” Hilton said of the Accountability for Congregate Care Act.
“This bill of rights provides protections that I wasn’t afforded, like access to education, to the outdoors, freedom from abusive treatment, and even the basic right to move and speak freely. If I had these rights and could have exercised them, I would have been saved from over 20 years of trauma and severe PTSD.”
Foster children, children being treated for mental disorders, and other children in youth programs would be impacted by the bill.
Hilton was one of several survivors and advocates who fought for the legislation on Wednesday. Rep. Khanna thanked them for using their stories to fight for change.
“No child should be subjected to solitary confinement, forced labor, or any form of institutional abuse,” he wrote. “Thanks to Paris Hilton, my colleagues & the survivors & advocates who joined us today to discuss how we can hold the congregate care industry accountable.”
While only Democratic legislators are currently sponsoring the bill, Hilton called for a bipartisan effort to fight for the rights of children.
“Ensuring that children are safe from institutional abuse isn’t a Republican or Democratic issue,” Hilton said. “It’s a basic human rights issue that requires immediate attention.”
See what others are saying: (The Washington Post) (The Hill) (NBC News)
Surgeons Successfully Test Pig Kidney Transplant on a Human
The procedure has been hailed as a major scientific breakthrough that could eventually open the door to a renewable source of desperately needed organs.
Surgeons at the NYU Langone Transplant Institute revealed Tuesday that they temporarily attached a kidney from a genetically modified pig to a human patient and found that it worked normally.
The operation was the first of its kind and could one day lead to a vast supply of organs for those who are in severe need. According to the Associated Press, more than 90,000 people in the U.S. are in line for a kidney transplant. Each day, an average of 12 die while waiting.
With the family’s consent, the groundbreaking procedure was performed on a brain-dead patient who was kept alive on a ventilator.
According to the surgeons, the pig used was genetically engineered to grow an organ that wouldn’t produce a sugar that the human immune system attacks, which would then trigger the body to reject the kidney.
The organ was connected to blood vessels on the patient’s upper leg, outside the abdomen, and it was observed for over 54 hours, with doctors finding no signs of rejection.
Concerns and Hurdles Ahead
While the procedure was successful, this doesn’t mean it’ll be available to patients anytime soon. Several questions about long-term functionality remain, and it will still have to go through significant medical and regulatory hurdles.
Details of the procedure haven’t even been peer-reviewed or published in a medical journal yet, though there are plans for this.
Experts are also considering the ethical implications of this type of animal-to-human transplant. For some, raising pigs to harvest their organs raises concerns about animal welfare and exploitation. Such medical procedures have already earned criticism from People for the Ethical Treatment of Animals, or PETA.
“Pigs aren’t spare parts and should never be used as such just because humans are too self-centered to donate their bodies to patients desperate for organ transplants,” PETA said in a statement, according to The New York Times.
On the other side of the debate are people like Dr. Robert Montgomery, the director of the N.Y.U. Langone Transplant Institute who performed the breakthrough procedure in September.
“I certainly understand the concern and what I would say is that currently about 40% of patients who are waiting for a transplant die before they receive one,” he told BBC.
“We use pigs as a source of food, we use pigs for medicinal uses – for valves, for medication. I think it’s not that different.”