Covid-19 Vaccine Development

[margarita25]

Effectiveness of the BNT162b2 Covid-19 Vaccine against the B.1.1.7 and B.1.351 Variants
https://www.nejm.org/doi/full/10.1056/NEJMc2104974

 

[margarita25]

CDC Director Statement on Pfizer’s Use of COVID-19 Vaccine in Adolescents Age 12 and Older
Media Statement
For Immediate Release: May 12, 2021
Coronavirus Disease 2019

 

[BetteDavisEyes]

Many Johnson & Johnson Covid vaccine doses may be close to expiring (nbcnews.com)

The buildup of unused doses is a result of safety concerns after the FDA paused distribution of the J&J doses, state health officials say.

As demand for Covid-19 vaccines declines across the country, unused Johnson & Johnson vaccine doses are piling up on state shelves, leaving state officials increasingly concerned that the lack of a coordinated federal plan to redistribute them means hundreds of thousands, if not millions, of doses will go to waste.

The buildup of doses is largely a result of the Food and Drug Administration's order in early April pausing distribution of the Johnson & Johnson vaccine because of safety concerns. Enthusiasm for the one-dose shot was dampened after the 11-day pause, according to state officials...

 

[Betty P]

Many Johnson & Johnson Covid vaccine doses may be close to expiring (nbcnews.com)

The buildup of unused doses is a result of safety concerns after the FDA paused distribution of the J&J doses, state health officials say.

As demand for Covid-19 vaccines declines across the country, unused Johnson & Johnson vaccine doses are piling up on state shelves, leaving state officials increasingly concerned that the lack of a coordinated federal plan to redistribute them means hundreds of thousands, if not millions, of doses will go to waste.

The buildup of doses is largely a result of the Food and Drug Administration's order in early April pausing distribution of the Johnson & Johnson vaccine because of safety concerns. Enthusiasm for the one-dose shot was dampened after the 11-day pause, according to state officials...

Why don't they arrange to ship them to other countries, where there's a shortage of vaccines?

 

[BetteDavisEyes]

FDA grants full approval to Pfizer's Covid vaccine (nbcnews.com)

Experts praised the decision, saying approval could help ease some vaccine hesitancy and pave the way for more vaccination mandates.

The Food and Drug Administration granted full approval to Pfizer-BioNTech's two-dose vaccine Monday for people ages 16 and up, making it the first Covid-19 vaccine to pass this final regulatory hurdle.

"The FDA's approval of this vaccine is a milestone as we continue to battle the Covid-19 pandemic," Acting FDA Commissioner Dr. Janet Woodcock said in a statement. "While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today's milestone puts us one step closer to altering the course of this pandemic in the U.S."...

 

[BetteDavisEyes]

Pfizer says its Covid vaccine is safe and effective for children ages 5 to 11 (nbcnews.com)

Pfizer and its German partner, BioNTech, said they would submit their data to the FDA for emergency use authorization.

Pfizer and BioNTech said Monday that the companies' two-dose Covid-19 vaccine was safe and showed a "robust" antibody response in children ages 5 to 11.

Based on data collected in a trial that included more than 2,000 children, Pfizer and its German partner, BioNTech, said in a press release that the vaccine was "safe, well tolerated, and showed robust neutralizing antibody responses" for this age group. No Covid vaccines have yet been authorized or approved for use in children under 12.

The children in the trial were given two smaller doses of the vaccine than those given to people 12 and older, according to the release...

 

[BetteDavisEyes]

Pfizer submits data to FDA, seeking to use its Covid vaccine for children ages 5 to 11 (nbcnews.com)

These younger kids could be vaccinated by Halloween, Pfizer CEO says.

Pfizer-BioNTech submitted data to the Food and Drug Administration to clear its Covid-19 vaccine for use in children ages 5 to 11, officials announced Tuesday.

The FDA is expected to take at least several weeks to analyze data collected in a trial that included more than 2,000 children before it would grant emergency use authorization...

 

[BetteDavisEyes]

FDA advisory group recommends 2nd J&J shot (nbcnews.com)

The second dose would be offered at least 2 months after the first.

A Food and Drug Administration advisory panel voted Friday to recommend a second Johnson & Johnson shot for emergency use authorization.

The vote in favor was unanimous, with panel members citing the need to supplement protection in people who were vaccinated with the Johnson & Johnson shot.

The decision will now go to the FDA, which is expected to make a final ruling in the coming days. The FDA doesn’t have to follow the guidance of the advisory panel, called the Vaccine and Related Biological Products Advisory Committee, although it usually does...

 

[BetteDavisEyes]

Moderna says its Covid vaccine has strong results in children ages 6 to 11 (nbcnews.com)

Data from an interim study showed two 50 microgram doses of the vaccine, half the strength of the doses used in the vaccine given to adults, generated virus-neutralizing antibodies in children.

Moderna Inc. said on Monday its Covid-19 vaccine generated a strong immune response and was generally well-tolerated in children ages 6 to 11, citing interim data from a study.

The company said it planned to submit the data to U.S., European and other regulators soon...

 

[BetteDavisEyes]

FDA advisory panel OKs Pfizer vaccine for kids 5 to 11 (nbcnews.com)

The move, if the FDA signs off on it, would expand eligibility to 28 million kids in the U.S.

A smaller dose of Pfizer-BioNTech’s Covid-19 vaccine cleared its first regulatory hurdle Tuesday for use in young children, after a Food and Drug Administration advisory committee voted to recommend it for emergency use authorization for those ages 5 to 11.

The 17-0 vote, with one abstention, will now go to the FDA, which is expected to make a final ruling in the coming days. If authorized, the move would make nearly the entire U.S. population eligible for a Covid shot. Only children ages 4 and younger would remain ineligible...

 

[BetteDavisEyes]

What pediatricians want parents to know about the Covid vaccine for kids (nbcnews.com)

Pediatricians share the questions they’re getting and how they respond.

As the Covid-19 vaccine has been rolling out for children ages 5 to 11, questions for pediatricians have been rolling in.

Many parents are simply wondering where they can find the long-awaited vaccine locally — and fast. Plenty other questions are from parents with a range of concerns about safety and effectiveness in kids.

Here are some common questions from parents, with advice from pediatricians around the country...

 

[weepingangel]

Study supports safety of COVID-19 vaccines in people with a history of severe allergic reactions

 

[weepingangel]

DEFINE_ME
Effectiveness of a third dose of the BNT162b2 mRNA COVID-19 vaccine for preventing severe outcomes in Israel: an observational study

• Noam Barda, MD *
• Noa Dagan, MD *
• Prof Cyrille Cohen, PhD
• Prof Miguel A Hernán, MD
• Prof Marc Lipsitch, DPhil
• Prof Isaac S Kohane, MD
• et al.
• Show all authors
  
• Show footnotes
  Published:October 29, 2021

 

[weepingangel]

Why Are We Microdosing Vaccines for Kids?
More at link
Children aren’t just miniaturized adults, and vaccines aren’t sandwiches: Pairing the two appropriately requires more than splitting shots into quarters or halves. The goal is to get the shot to be not just kid-size, but kid-friendly, which meansfinagling a whole slew of factors, including dosing—but also how vaccine recipes are stabilized and stored, how much liquid gets injected into arms, and even who doles the vaccines out and the color of the vials they use.

 

[CrimeAway]

Moderna chairman responds to questions about Omicron, and mentions NEW vaccines that they currently have in development and testing:

 

[CrimeAway]

This Week In Virology's (TWIV) latest episode includes discussion of Covid vaccine timing and immune response and whether a longer interval between the first 2 doses leads to a stronger response. This touches on the current recommendation for a third booster dose, and the pros and cons of extending the interval between dose 1 & 2. Also, a paper looking at immune responses to vaccination following infection is discussed. It seems that the mRNA vaccines may have been better (?) if they had originally been designed to be given as a series of 3, but of course in a pandemic, scientists were trying to get effective vaccines out to the public ASAP. JMO.

Brought this over from the main thread. Hope this is ok @margarita25

 

[CrimeAway]

A link to some scientific papers detailing immune responses to Sars-coV-2 vaccines after infection, and also with differing timing of vaccination (between doses).

1) Robust immune responses are observed after 1 dose of mRNA vaccine (BNT162b2/Pfizer) in Sars-coV-2 "experienced" individuals
AAAS

2) Higher Antibody Response Is Generated With a 6- to 7-Week (vs Standard) Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccine Dosing Interval

3) Strong humoral immune responses against SARS-CoV-2 Spike after BNT162b2 mRNA vaccination with a 16-week interval between doses - ScienceDirect

 

[margarita25]

Copying over from @BetteDavisEyes’s post from main thread:

Pfizer pulls FDA request for Covid vaccine for kids under 5 (nbcnews.com)
Feb 11, 2022

The company said it believes three doses "may provide a higher level of protection in this age group."

Pfizer-BioNTech is postponing its rolling application to the Food and Drug Administration to expand the use of its two-dose Covid-19 vaccine for children ages 6 months to 4 years.

The move means that vaccines for this age group will not be available in the coming weeks, a setback for parents eager to vaccinate their young children.

Pfizer said on Friday that it will wait for its data on a three-dose series of the vaccine, because it believes three doses "may provide a higher level of protection in this age group." Data on the third dose is expected in early April, the company said...

 

[margarita25]

 

[BetteDavisEyes]

FDA authorizes a 2nd Covid booster shot for people 50 and older (nbcnews.com)

The move comes as fewer than half of those eligible for their first booster shot have received one.

The Food and Drug Administration on Tuesday authorized a second booster dose of the Pfizer-BioNTech and the Moderna Covid-19 vaccines for adults ages 50 and older.

People are eligible to get the additional dose at least four months after receiving their first booster, the FDA said in a statement.

Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, is expected to release a statement signing off on the additional shot shortly.

The FDA has already authorized a fourth shot for immunocompromised individuals...