Covid-19 Vaccine Development

Colorado pauses use of Johnson & Johnson COVID-19 vaccine after joint FDA and CDC announcement | Colorado COVID-19 Updates

“(April 13, 2021):
In response to the joint CDC and FDA announcement and out of an abundance of caution, today the Colorado Department of Public Health and Environment (CDPHE) and the Colorado Joint Vaccine Task Force are alerting providers to temporarily pause use of the Johnson & Johnson (Janssen) COVID-19 vaccine.

Federal health officials recommended temporarily suspending use of the vaccine after reviewing reports of six individuals in the U.S. who got rare and severe blood clots after receiving the vaccine. The federal government is allowing states to determine whether to pause use, and CDPHE is requiring providers to stop administration of the Johnson & Johnson (Janssen) vaccine until additional information becomes available. One of the reasons the FDA and CDC are recommending this pause is to ensure health care providers are aware of these potential but rare adverse events and can respond accordingly. The treatment for these types of blood clots is not the common treatment and thus time is needed to make sure healthcare providers know how to recognize and treat these rare occurrences. “



https://www.thedenverchannel.com/ne...aused-in-colorado-heres-what-you-need-to-know

“How does the Johnson & Johnson vaccine differ from the others?

Johnson & Johnson’s Janssen COVID-19 vaccine is a viral vector vaccine, which means it uses a modified version of a different virus (the vector) to deliver instructions to cells to produce the COVID-19 spike protein, according to the Center For Disease Control and Prevention.

The body’s immune system will then produce antibodies as it attacks the harmless spiked protein cells, building an immunity to the actual COVID-19 virus.

Viral vector vaccines were created in the 1970s, and have been studied for gene therapy, to treat cancer, and for molecular biology research, according to the CDC.

The Moderna and Pfizer vaccines are mRNA vaccines, which are a new type of vaccines. These type of vaccines give instructions to cells to make a harmless piece of the spike protein that is found on the surface of the COVID-19 virus, according to the CDC.“



“On Tuesday, the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) recommended a pause on the usage of the J&J vaccine as they investigated six reports of potentially dangerous blood clots.

After the CDC announcement, CDPHE and the Colorado Joint Vaccine Task Force announced a pause on the vaccine in Colorado, too.”

Colorado COVID: Polis gives update on state's response | 9news.com
 
Johnson & Johnson Covid-19 vaccine: CDC and FDA recommend US pause use of vaccine over blood clot concerns - CNN

“The US Centers for Disease Control and Prevention and the US Food and Drug Administration are recommending that the United States pause the use of Johnson & Johnson's Covid-19 vaccine over six reported US cases of a "rare and severe" type of blood clot.”

[...]

“The six reported cases were among more than 6.8 million doses of the Johnson & Johnson vaccine administered in the United States.“

[...]

“"CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance," the statement said. "FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot."“



 
EXPLAINER: What's known about J&J's vaccine and rare clots

April 12, 2021

The U.S. recommended that states pause giving the J&J vaccine on Tuesday while authorities examine six reports of the unusual clots, including a death, out of more than 6.8 million Americans given the one-dose vaccination so far.

But the small number of cases sparked concern because just last week, European authorities said similar clots were possibly linked to the AstraZeneca vaccine, which is not yet OK’d in the U.S. That led some countries to limit its use to certain age groups.

[..]

WHAT MAKES THESE CLOTS DIFFERENT?

These are not typical blood clots. They’re weird in two ways.

First, they’re occurring in unusual parts of the body, such as veins that drain blood from the brain. Second, those patients also have abnormally low levels of platelets -- cells that help form clots -- a condition normally linked to bleeding, not clotting.

Scientists in Norway and Germany first raised the possibility that some people are experiencing an abnormal immune system response to the AstraZeneca vaccine, forming antibodies that attack their own platelets. That’s the theory as the U.S. now investigates clots in J&J vaccine recipients, Dr. Peter Marks, the Food and Drug Administration’s vaccine chief, said Tuesday.

WHY SUSPECT IMMUNE RESPONSE?

The first clue: A widely used blood thinner named heparin sometimes causes a very similar side effect. Very rarely, heparin recipients form antibodies that both attack and overstimulate platelets, said Dr. Geoffrey Barnes, a clot expert at the University of Michigan.

“It kind of can cause both sides of the bleeding-clotting spectrum,” Barnes said.

Because heparin is used so often in hospitals, that reaction is something “that every hospital in America knows how to diagnose and treat.”

There also are incredibly rare reports of this weird clot-low platelet combination in people who never took heparin, such as after an infection. Those unexplainable cases haven’t gotten much attention, Barnes said, until the first clot reports popped up in some AstraZeneca vaccine recipients.

Health officials said one reason for the J&J pause was to make sure doctors know how to treat patients suspected of having these clots, which includes avoiding giving heparin.

The Centers for Disease Control and Prevention later Tuesday provided advice on how to spot and treat the unusual clots.

WHAT DOES RESEARCH SHOW?

In two studies in the New England Journal of Medicine last week, research teams from Norway and Germany found platelet-attacking antibodies in the blood of some AstraZeneca vaccine recipients who had the strange clots. The antibodies were similar to those found with the heparin side effect even though the patients had never used that blood thinner.

It’s not yet clear if there’s a similar link to the J&J vaccine. But the J&J and AstraZeneca vaccines, as well as a Russian COVID-19 vaccine and one from China, are made with the same technology. They train the immune system to recognize the spike protein that coats the coronavirus. To do that, they use a cold virus, called an adenovirus, to carry the spike gene into the body.

FDA’s Marks wouldn’t say if the weird clots may be common to these so-called adenovirus-vector vaccines. In addition to the AstraZeneca data, J&J makes an Ebola vaccine the same way and he said authorities would examine “the totality of the evidence.”

WHAT ABOUT OTHER VACCINES?

The most widely used COVID-19 vaccines in the U.S. -- from Pfizer and Moderna -- are made with a completely different technology, and the FDA said there is no sign of a similar clot concern with those vaccines.
 
Given that the women who developed blood clots are in the 18-48-year-old range (child-bearing age), I can't help wondering if there is an estrogen link? The age range of the women is mentioned in many reports and by experts who chimed in on the subject yesterday.
 
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Given that the women who developed blood clots are in the 18-48-year-old range (child-bearing age), I can't help wondering if there is an estrogen link? The age range of the women is mentioned in many reports and by experts who chimed in on the subject yesterday.
I definitely agree. Also, listening to a program this morning and they cited the blood clot and vaccine stats similar to that found with birth control pills.
 
Given that the women who developed blood clots are in the 18-48-year-old range (child-bearing age), I can't help wondering if there is an estrogen link? The age range of the women is mentioned in many reports and by experts who chimed in on the subject yesterday.

Can't recall the researcher's name, but they were discussing this possibility on the news this morning - from our local CBS affiliate. It may be hormone related, possibly specific to a type of birth control. They'll be gathering more info on the patients who had a problem. Hopefully it will work out. If not, they can rely on the others, the mRNA vaccines.

Here's another article

J&J vaccine blood clot: Cause of rare side effect in COVID vaccines?

"If you mistreat it, people die," she said, "and if you don't treat it, there's still a high mortality associated with it."

But it can be treated if doctors are looking for it.

There are other blood thinners that can treat it.
 
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I’m subscribed to an Apple podcast, “Coronavirus Fact vs. Fiction” with Dr. Sanjay Gupta. Today his podcast is focused specifically on the pause of the J&J vaccine:

“CNN’s Chief Medical Correspondent Dr. Sanjay Gupta walks through what we currently know about the CDC and FDA's decision to pause the use of Johnson & Johnson's Covid-19 vaccine, what this means for people who recently received a J&J shot, and why he isn’t panicking.”

‎Coronavirus: Fact vs Fiction on Apple Podcasts
 
Stanford begins testing Pfizer COVID-19 vaccine on children as young as 2

“As statewide eligibility for the COVID-19 vaccine expands to residents 16 and older in California, researchers at Stanford Medicine have set their sights on an even younger group: children ages 2 to 5.

The medical school Wednesday began administering doses to children in the tender age group as part of a larger, three-phase trial of Pfizer-BioNech’s COVID-19 vaccine that will ultimately include children ages 6 months to 12 years.

“We want to protect children just as we want to protect adults from this disease,” said Dr. Yvonne Maldonado, the pediatric infectious diseases expert leading the trial at Stanford. “The goal is to have a pediatric vaccine available for all age groups from 6 months of age to adulthood.”“
 
Pfizer says third dose likely - Booster:



Pfizer CEO says third Covid vaccine dose likely needed within 12 months

“A likely scenario is that there will be likely a need for a third dose, somewhere between six and 12 months and then from there, there will be an annual revaccination, but all of that needs to be confirmed. And again, the variants will play a key role,” he told CNBC’s Bertha Coombs during an event with CVS Health.”



Annual Covid-19 Vaccine Booster Shots Likely Needed, Pfizer CEO Says
Albert Bourla said more research is needed but it looks likely booster shots required within a year to stay ahead of virus variants

“Countries with high vaccination rates will be ready to shift their focus to boosters possibly at the end of this year, Moderna said during a company vaccine event this week. Moderna President Stephen Hoge said it is safe to assume boosters would be needed “annually, probably seasonally, even though the pandemic is raging in a nonseasonal way.”“

The Moderna and Pfizer-BioNTech vaccines are based on a new gene-based technology called messenger RNA. The likelihood that periodic Covid-19 shots will be needed is one reason Pfizer executives have said the company plans to expand its vaccine business by becoming a leader in mRNA.



Moderna CEO sees likely need for COVID booster for high-risk groups, eyes flu market

“The pandemic still continues to claim casualties around the world, challenging efforts by the U.S., Britain and Israel, which have inoculated their citizens at an impressive pace.

"Discussions now are really turning to 2022, and governments being worried about boosts," Bancel said.“
 
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Covid-19 booster shot likely needed within 12 months, Pfizer's CEO says (nbcnews.com)

People may also need annual shots to protect against the coronavirus, he said, similar to the seasonal flu.

People are likely to need a third dose of a Covid-19 vaccine within a year of getting fully vaccinated and may subsequently need annual shots to protect against the coronavirus, Pfizer CEO Albert Bourla said Thursday.

Pfizer and its German partner, BioNTech, are studying how long the vaccines' protective immunity will last. Their findings will guide whether additional booster shots will be necessary.

Bourla said it's "likely" that a booster will be needed within 12 months of the initial two-shot regimen...
 
Given that the women who developed blood clots are in the 18-48-year-old range (child-bearing age), I can't help wondering if there is an estrogen link? The age range of the women is mentioned in many reports and by experts who chimed in on the subject yesterday.

Me too. And women in general are having more side effects.
 
U.S. COVID-19 vaccine program meets key goal, but India cases and Brazil deaths worry experts
April 19, 2021

“The U.S. vaccine program was in high gear on Monday, with the news that all American adults are now eligible for a shot, meeting a key goal of President Joe Biden’s coronavirus team set two weeks ago.

In further positive news, the Centers for Disease Control and Prevention says half of American adults have received at least one shot of the two-dose regimens developed by Pfizer Inc. and German partner BioNTech SE and Moderna Inc., as the Associated Press reported.

[...]

“The European Union may not renew its COVID-19 vaccine contract with AstraZeneca after the Anglo-Swedish drug company persistently failed to deliver what it promised, the Guardian reported. “My priority, as the person in charge of vaccine deliveries, is that those we have contracts with deliver the quantities stipulated at the time stipulated,” Thierry Breton, European commissioner overseeing deliveries, told French TV station BFM-TV

• Austria will only use Russia’s Sputnik V coronavirus vaccine once the European Medicines Agency has approved it, Chancellor Sebastian Kurz said on Monday, Reuters reported. Austria has been in talks with Russia to buy a million doses of the vaccine, and Kurz said on March 31 that the order would probably be placed the following week. That order has yet to be announced.”
 

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