Monday, Pfizer released results from a study that shows their COVID vaccine is effective for children aged 5 to 11.
Monday, September 20th 2021, 5:32 pm
Pfizer released good news Monday on the COVID-19 vaccine front.
In a study with over 2,000 kids ages 5 to 11, Pfizer and Biontech officials said the vaccine was safe, well tolerated and showed robust neutralizing antibody responses.
The dosage for the children 5 to 11 is less than the dosage for those 12 and over. But it is a still a two-dose regimen taken 21 days apart.
This is the first pivotal trial of any COVID-19 vaccine for children under 12. Officials said they hope to submit this data to the FDA and other agencies as soon as possible.
"The risk of hospitalization and death is much lower in children who get COVID," said Dr. Dale Bratzler, OU Health's Chief COVID-19 officer. "But it's not zero and some kids get very sick, and they can also bring it home to adults."
Bratzler was excited about the data but knows some parents might be hesitant at first.
"I know there are a lot of parents out there that are waiting and will get their kids vaccinated and I know there are some parents that will take a step back wait and see," said Bratzler.
But kids can't get it just yet. The vaccine needs to get emergency use authorization from the FDA and then the CDC advisory panel will give the final guidance for administering the vaccine to this age group.
"I am going to say a month to six weeks at the maximum," said Bratzler. "It will be a very important step to reduce the case counts in Oklahoma to get as many children vaccinated as we possibly can."
There is a study for kids under the age of 5. Those results are expected to come out this year.
The Oklahoma City VA Health Care System will be offering the first dose of the Pfizer COVID-19 vaccine on Saturday.
Saturday, January 30th 2021, 10:23 am
By: News 9
The Oklahoma City VA Health Care System provided the first dose of the Pfizer COVID-19 vaccine to veterans on Saturday.
The VA was able to administer the first dose of the Pfizer COVID-19 vaccine to more than 150 veterans over the age of 65 and helped them set-up an appointment for their second dose.
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Officials say a dozen MTA workers are off the job today following accusations of submitting fake COVID-19 vaccination cards.
The MTA Inspector Generals Office says a Metro-North employee was fired and 11 Long Island Railroad workers were suspended without pay.
Officials say the groups vaccination cards were provided by Julie Devuono, of Amityville, the owner of Wild Child Pediatric Healthcare.
As News 12 has reported, Devuono confessed to forging vaccination cards. Prosecutors say her company made more than $1 million in the scheme.
Four of the LIRR workers admitted they were never actually vaccinated.
COVID-19 mRNA vaccines stimulated mucosal immunity in people previously infected with SARS-CoV-2, but generated only a tiny amount of immunity in people who had never been infected, according to a cohort study using data from the French CoviCompare trials.
Among trial participants who received the Moderna mRNA-1273 (Spikevax) vaccine in early to mid 2021, SARS-CoV-2 spike-specific saliva IgA levels were significantly higher in those with previous infection compared with the most responsive SARS-CoV-2-naive participants at day 180 (P<0.001), reported Guy Gorochov, MD, PhD, of Sorbonne University in Paris, and colleagues in JAMA Network Open.
In participants without prior infection, compared with day 1, increases of specific salivary IgA levels were smaller, especially after vaccination with the Pfizer-BioNTech BNT162b2 (Comirnaty) vaccine, reaching statistical significance only at day 57 (P=0.01).
SARS-CoV-2 spike-specific IgG saliva levels increased after one or two shots in participants with previous infection and those who never had infection.
"Until now, there was still a considerable controversy in the literature regarding the capacity of intramuscular mRNA vaccination to induce a mucosal immune response," Gorochov told MedPage Today in an email. "In this study, we show that current vaccines can, at best, induce traces of specific antibodies in the saliva in individuals that were never infected by the virus before vaccination."
"After intramuscular vaccination, we did not expect to detect SARS-CoV-2-specific secretory IgA antibodies" in the saliva of SARS-CoV-2-naive people, he said. "Since the vaccine is injected in muscles, we expected an appearance of specific antibodies in the serum, but not in secretory body fluids for induction of a protective barrier effect."
"It is very important to underline that a clear stimulation of mucosal immunity [was] only observed in vaccinees with prior SARS-CoV-2 infection," he added, despite the detection of small amounts of spike-specific salivary IgA in vaccinated SARS-CoV-2-naive participants.
"Nasal delivery of vaccines might one day improve their local efficacy," Gorochov noted. "Further studies would then be needed to address the association between local secretory IgA levels and prevention of infection or transmission of SARS-CoV-2."
IgA is the principal immunoglobulin isotype in secretions of the respiratory and intestinal tracts, whereas IgG is the principal isotype found in serum and extracellular fluid. IgA is monomeric in human serum but is also produced locally in mucosal tissues mostly under dimeric or even polymeric forms and released as secretory IgA, the authors wrote. Monomeric IgA is also present in saliva following passive transport from blood.
The mRNA-1273 vaccine appeared to elicit a stronger immune response than the BNT162b2 vaccine. Among the SARS-CoV-2-naive patients, serum anti-spike IgG and IgA levels were significantly higher among people who received the mRNA-1273 vaccine (P<0.001 for all comparisons).
This study included 180 patients from the CoviCompare M trial and 267 patients from the CoviCompare P trial, enrolled from February 19 to June 8, 2021 in France. After exclusions, 427 participants were included in this study. Of these, 120 had a documented SARS-CoV-2 infection at least 5 months before receiving a single dose of the BNT162b2 vaccine. The remaining 307 patients had received two doses of either the mRNA-1273 vaccine or the BNT162b2 vaccine and had no prior documented SARS-CoV-2 infection. The median age of participants was 68 years, and 53.4% were men.
The researchers measured total saliva IgA and IgG, SARS-CoV-2 spike- and nucleocapsid-specific serum antibodies, and secretory SARS-CoV-2-specific IgA using enzyme-linked immunosorbent assay (ELISA) tests. Ultrasensitive digital ELISA technology was used to measure and compare spike-specific serum and salivary IgG and IgA levels.
The main limitation of the study was that the authors were unable to determine whether the increase in specific secretory IgA in infection-naive individuals could be attributable to asymptomatic or seronegative exposures to SARS-CoV-2, Gorochov said.
Katherine Kahn is a staff writer at MedPage Today, covering the infectious diseases beat. She has been a medical writer for over 15 years.
Disclosures
The studies were funded by the Ministre des Solidarits et de la Sant and Ministre de l'Enseignement Suprieur, de la Recherche et de l'Innovation, the ANRS Maladies Infectieuses mergentes, and Assistance Publique-Hpitaux de Paris.
Gorochov reported no relevant financial disclosures, but several co-authors reported ties to industry, including Pfizer and Moderna.
Primary Source
JAMA Network Open
Source Reference: Gorochov G, et al "Serum and salivary IgG and IgA response after COVID-19 messenger RNA vaccination" JAMA Netw Open 2024; DOI: 10.1001/jamanetworkopen.2024.8051.
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GSK (NYSE:GSK) is reportedly suing Pfizer (PFE) and partner BioNTech (BNTX) for patent infringement over the use of certain mRNA technology for their COVID-19 Comirnaty vaccines.
GSK, also known as GlaxoSmithKline, filed the suit in a Delaware federal court on Thursday, alleging that Pfizer and BioNTech's Comirnaty vaccines infringe upon vaccine technology developed by GSK, according to Reuters.
A Pfizer spokesperson told Reuters that the company was confident in its intellectual property position on the vaccines and would vigorously defend itself against the claims in court.
The case is the latest filed by GSK against Pfizer over technology used in its vaccines. Last year, GSK sued Pfizer, alleging that Pfizers RSV vaccine Abrysvo infringed upon GSKs patents for its RSV vaccine Arexvy.
In 2022, COVID-19 vaccine developer Moderna (MRNA) also sued Pfizer and BioNtech for patent infringement over Comirnaty. The case is ongoing.
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The U.S. Department of Agriculture on Wednesday issued a federal order that any dairy cows being transported from one farm to another across state lines should be tested for bird flu.
The new order comes one day after the Food and Drug Administration said that fragments of the bird flu virus were found in samples of pasteurized milk on store shelves. On Wednesday, the FDA said that, in order to identify where the contaminated milk was found, it was conducting a nationwide survey of commercially sold milk and would release its results in the coming days.
When the outbreak was first detected at the end of March, in an effort to keep the milk supply safe, farmers were instructed to discard the milk of sick cows, Don Prater, acting director of the FDA's Center for Food Safety and Applied Nutrition, said during a joint media briefing Wednesday.
Farmers were also told by the USDA to test symptomatic cows.
The discovery of the virus in the commercial milk supply, however, indicates those approaches weren't enough.
It's unclear how the new mandate might curb the spread of the virus a strain of the bird flu called H5N1 among the nations cattle. The virus has already been detected in dairy cows in eight states:Idaho, Kansas, Michigan, New Mexico, North Carolina, South Dakota, Ohio and Texas.
A big question for scientists now is, how long has it been going on and where else has it spread?
"I think it's safe to say that it's longer and much more extensive that has been realized," said Dr. Michael Mina, an epidemiologist and former professor of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health.
The outbreak concerns scientists and public health officials because H5N1 can be especially deadly in people. However, once in people, the virus doesn't spread easily.
Dr. Nirav Shah, principal deputy director of the Centers for Disease Control and Prevention, said during the media briefing that there's no indication that the H5N1 flu strain is causing any uptick in illness among people or poses an immediate danger to the public.
CDC has not identified any out-of-the-ordinary influenza-related emergency department visits, even when we compare areas where H5N1 has spread among cattle against areas where it has not, Shah said.
One person, a dairy worker in Texas, was infected earlier this month. The CDC said that the case was mild and the worker developed conjunctivitis, or pink eye.
Shah noted that another 44 people are being actively monitored, for illness.
In addition to testing dairy cows before transporting them, Wednesday's order also requires that state veterinary labs report any positive tests to federal health authorities.
If [the cows] end up testing positive, they will have a 30-day waiting period before they could move and have to be tested again, Mike Watson, administrator for the USDA's Animal and Plant Health Inspection Service, said during the media briefing.
The worry is not whether people can catch the flu by drinking milk. The U.S. milk supply undergoes a mandatory pasteurization process, heating milk to a point where any bacteria or virus should be killed.
Though the FDA has not completed studies specifically looking at whether pasteurization kills the virus that causes bird flu, the agency said on Tuesday that, "to date, we have seen nothing that would change our assessment that the commercial milk supply is safe."
The FDA plans to release results of studies looking at pasteurization's effects on the bird flu virus in the coming days or weeks.
Erika Edwards is a health and medical news writer and reporter for NBC News and "TODAY."
Akshay Syal, M.D.,is a medical fellow with the NBC News Health and Medical Unit.
Marina Kopf contributed.
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By Julie Steenhuysen
CHICAGO, April 25 (Reuters)-U.S. officials have strengthened measures to contain the further spread of the first known outbreak of H5N1 or bird flu in dairy cows, which hasnowspread to 33 herds in eight states and bled over into the country's milk supply.
So far, only one person - a Texas farm worker - hastested positive for H5N1, and while health officials and scientists say the risk to people remains low, many questions remain.
The spread of bird flu among dairy cattle reflects an expansion of the range of mammals that can be sickened by the virus that typically infects birds.
Scientists are on alert for changes in H5N1 that could signal the virus is adapting to spread easily among humans. The virus has caused serious or fatal infections among people in close contact with wild birds or poultry. It has long been on the list of viruses with pandemic potential, and any expansion to a new mammal species is concerning.
The infections in cattle are from the same subtype of bird flu that has been infecting wild birds and poultry flocks globally for more than two years, alsokilling several mammal speciesthat likely contracted the virus from consuming sick or dead birds.
How widespread is the bird flu outbreak in cattle?
The full extentremains unknown, but several recent developmentssuggest it may be in more herds than documented.
On April 23, the U.S. Food and Drug Administration said it has detected particles of H5N1 in the milk supply. Tests suggest they are remnants of virus killed during the pasteurization process, and that the milk is safe.Early testing has not detected any live virus in milk samples, andU.S. health officials believe people cannot get sick from drinking pasteurized milkand warn not to drink unpasteurized milk.
Officials have learned the virus can be present in cows that show no signs of infection, and milk from those cows doesnot show signs of infection such as being thicker and yellow.
To contain the outbreak,the U.S. government is requiring dairy cattle moving between statesto be tested for bird flu.
U.S. officials had thought the outbreak was recent,but new information suggests it may have started late last year.
After the U.S. Department of Agriculture releasedsomeraw genetic data onto a public database on April21, a team of evolutionary biologists led by Dr. Michael Worobey of the University of Arizona pieced together the viral genetic codes.
The team mapped the outbreak by tracking changes in the virus as it spread among herds. Based on their analysis, Worobey said in an April 24 interview that the outbreak in dairy cattle occurred through a single transmission event from a bird to a cow in late 2023, likely in December.
It is still unclear how the virus is spreading, butthere is evidence ofwild bird-to-cow, cow-to-cow, cow-to-poultry, and one case of cow-to-human transmission. There is no evidence of human-to-human transmission.
Because of the heavy viral load in milk and mammary glands, scientists suspect the virus is being spread to animals during the milking process, either through contact with infected equipment or with virus that becomes aerosolized during cleaning procedures.
Whether the virus can spread through respiratory droplets that infect the airway, as flu viruses typically spread in humans, remainsunclear.
The U.S. has a stockpile of bird flu vaccines matched with the strain currently circulating, as well as antivirals that could be used to treat human infections. For a major epidemic or a pandemic, the U.S. would have to scale up considerably.
Flu vaccine suppliers SanofiSASY.PA, GlaxoSmithKlineGSK.Land CSL SeqirusCSL.AXhave said they are monitoring avian flu and stand ready.
(Reporting by Julie Steenhuysen and Tom Polansek in Chicago; Editing by Caroline Humer and David Gregorio)
