Top Line

Pharma giant Pfizer said on Tuesday it would ask regulators to approve a vaccine designed to protect babies from respiratory syncytial virus, or RSV, after strong results in late-stage clinical trials that have been common but potential. There is a potential gamechanger in efforts to tackle the deadly infection. Cases mount and the children’s hospital struggles to cope.

Key Facts

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Pfizer plans to ask the Food and Drug Administration to authorize an RSV vaccine designed to protect infants by the end of the year, the company said, citing strong results from clinical trials of late .

The company said a shot given at the end of the second to third trimester of pregnancy was highly effective in protecting newborns during their first months of life.

The shot was about 82% effective at preventing a severe form of lower respiratory tract disease from RSV during the first 90 days of a child’s life, Pfizer said, and was about 70% effective in the first six months.

Pfizer said the vaccine cut the number of doctor visits due to respiratory illness caused by RSV on average by more than 50% compared to a placebo, noting that it met its goal outlined at the start of the trial. failed to complete. The result was considered clinically meaningful.

Pfizer said that since June 2020, about 7,400 pregnant people and their newborns from 18 different countries were tested—the babies were followed for at least one year after birth and half were followed for two.

No safety concerns for parents or children were identified during the trial and the vaccine was well tolerated, Pfizer said, adding that it plans to submit the results for peer review in a scientific journal. and will receive approval from additional regulators in the coming months. ,

news peg

There are children's hospitals across America struggling to cope a big one. with surge The number of RSV infections, which decreased during the COVID-19 pandemic. The spike in infections, although not uncommon, has come unseasonably early and is particularly severe and is accompanied by an increase in other Covid-19 and flu are feeling hospital-like infections stress,

what to see

If approved, Pfizer's vaccine would be the first shot on the market to protect against RSV. Pfizer is also investigating the shot's potential in older adults who are also at risk from RSV, and in August Told Trials showed it to be effective in this group. Pfizer is one of number Pharmaceutical firms including Moderna, Johnson & Johnson and GlaxoSmithKline have focused on developing an RSV vaccine that contains could not be found Scientists for decades, though most of this focused on older adults. GlaxoSmithKline is close Back Pfizer and then are expected to receive regulatory approval in the near future. announcement of Promising results of the trial in October.

main background

RSV is a common respiratory virus that most people can easily overcome. It can cause mild, cold-like symptoms including runny nose, cough, sneezing, loss of appetite and fever. according to the CDC, and the agency is so common They say "Almost all children" have already had RSV infection by the age of two. For very young infants, older adults, and people with compromised immune systems, however, RSV can be fatal and may even trigger more serious infections, such as pneumonia. it is the biggest killer of young infants worldwide after malaria, kills Every year in the US 100 to 300 children under the age of five and Responsible There are no specific treatments or vaccines for the 14,000 deaths in adults aged 65 and older in the US, and experts recommend hand-washing and cleaning surfaces as some of the best ways to prevent infection, which causes coughs and sneezes. gets passed through and can persist for a long time. surface for hours.

RSV infections are on the rise and children's hospitals are flooding – here's what parents need to know (Forbes)

For decades, fear and failure in the search for an RSV vaccine. Now, success. (Washington Post)

The race to make a vaccine for a dangerous respiratory virus (Nature)