New York Primary Care and Family Practice Medical Clinic | UHS

Pfizer Says Maternal RSV Shot Gives Strong Protection To Newborns

Pfizer has bolstered the evidence behind its respiratory syncytial virus (RSV) vaccine with a positive trial of the shot used to protect newborns, adding to earlier results in older adults.

The phase 3 MATISSE study of RSVpreF given to pregnant women in order to protect their babies after birth found that the vaccine had efficacy of 81.8% in preventing lower respiratory tract infections caused by RSV in the first 90 days of life, falling to 69.4% at six months.

It also reduced infants' risk of needing medical intervention for an RSV infection by around half in the first six months, although that was not a statistically significant difference.

Armed with the new data, Pfizer intends to file for approval of RSVpreF as a maternal immunisation before the end of the year, as an addition to its plans to submit the shot for older adults based on the results of its recently reported RENOIR trial.

The adult population is a much bigger market for a potential RSV vaccine, although maternal immunisation would be a valuable add-on, and one in which Pfizer has a clear lead over its main rival, GSK.

GSK has also reported high levels of protective efficacy with its RSV vaccine candidate in older adults, but was forced to halt trials of its shot in expectant mothers earlier this year over as-yet undisclosed safety concerns.

"This is the first-ever investigational vaccine shown to help protect newborns against severe RSV-related respiratory illness immediately at birth," said Pfizer's head of vaccine R&D, Dr Annaliesa Anderson.

"We look forward to working with the FDA and other regulatory agencies to bring this vaccine candidate to expectant mothers, to help protect their infants against severe RSV during their most vulnerable first six months of life, which has the highest burden of RSV illness in infants."

That timeframe would make Pfizer's vaccine an alternative to antibody-based therapies that are given not to the mother, but to the infants themselves, to protect against RSV in the crucial first few months of life.

AstraZeneca and Sanofi are out in front in this category with nirsevimab, a long-acting antibody designed to provide passive protection to infants through their first RSV season with a single dose, which has already been filed for approval in the US and Europe.

It will compete with Sobi's established antibody therapy Synagis (palivizumab), an antibody originated by AZ, which is dosed once a month.

Family Demands Justice For Father-to-be Fatally Shot On His 19th Birthday

CLEVELAND (WOIO/Gray News) - A Cleveland family is facing an awful reality, knowing a baby will have to grow up without his dad, after a 19-year-old father-to-be was shot and killed on his birthday.

Juaquim Torres, 19, was shot and killed around 7:10 p.M. Friday while walking home to celebrate his birthday in Cleveland. He was left to die on a sidewalk, WOIO reports.

Family and close friends of Torres, who was also called Jack, gathered Sunday at a memorial set up at the spot where he took his last breath. They say the 19-year-old had his entire life ahead of him and a baby on the way. Now, instead of celebrating his birthday, they are forced to plan his funeral.

Juaquim Torres, a 19-year-old father-to-be, was shot and killed while walking home to celebrate his birthday.(Source: Courtesy of GoFundMe)

Through tear-filled eyes, Torres' grandmother, Edith Ellis, said he was her heart.

"He was so excited about his child, so excited. He was also excited about graduating and walking across the stage to receive his diploma next month," Ellis said. "Now, there's no graduation, and he'll never see his child. For what? There's no reason."

For Daniela Jones, who is 5 months pregnant with Torres' child, this is a nightmare she can't wake up from. What she was looking forward to has been taken away.

"Getting the chance to see him be a father is what I will miss most," Jones said. "He was so excited about it... He had already picked a name before we knew the gender."

Family and friends gathered around the memorial of candles and balloons to hold hands and pray. Through their tears and long embraces, they are demanding justice for Torres.

The 19-year-old's sister, Jamie Hloska, was especially distraught, angry and determined to get justice. She used paint to write on the sidewalk the following words: "You still matter."

"They robbed him of his life. He can't be the father to his child. All he had to do was graduate and become a father. He didn't even get to meet his child," Hloska said.

Loved ones, including Hloska, believe the killer is someone Torres knew and trusted.

"I have to put my brother in the ground," Hloska said. "He did what he was supposed to. He didn't deserve this."

Torres absolutely loved his family, according to his grandmother, and ironically, it's his death that has finally brought them all together.

"I've tried for years to get them together. They won't even talk to each other, half of them. It took my grandson's death to bring this family together. Everybody loved him, so everybody pulled together," Ellis said.

Torres' family has set up a GoFundMe, hoping to raise enough money to give him a proper funeral and burial. They are also hoping police can provide them with some answers about what led up to the deadly shooting.

At this point, no arrests have been made.

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