{"id":18571,"date":"2020-12-07T17:36:41","date_gmt":"2020-12-07T17:36:41","guid":{"rendered":"http:\/\/evaggelatos.com\/?p=18571"},"modified":"2020-12-09T17:39:38","modified_gmt":"2020-12-09T17:39:38","slug":"18571","status":"publish","type":"post","link":"https:\/\/evaggelatos.com\/?p=18571","title":{"rendered":"\u039f\u03b9 \u03c6\u03b1\u03c1\u03bc\u03b1\u03ba\u03b5\u03c5\u03c4\u03b9\u03ba\u03ad\u03c2 \u03b2\u03b9\u03bf\u03bc\u03b7\u03c7\u03b1\u03bd\u03af\u03b5\u03c2 \u03c3\u03c4\u03bf \u03c6\u03cc\u03c1\u03c4\u03b5 \u03c4\u03bf\u03c5\u03c2 \u03b3\u03b9\u03b1 \u03bd\u03b1 \u03bc\u03b1\u03c2 \u03c3\u03ce\u03c3\u03bf\u03c5\u03bd! \u0395, \u03ba\u03ac\u03c4\u03b9 \u03b8\u03b1 \u03c8\u03b9\u03bb\u03bf\u03ba\u03b5\u03c1\u03b4\u03af\u03c3\u03bf\u03c5\u03bd \u03ba\u03b9 \u03b1\u03c5\u03c4\u03ad\u03c2!"},"content":{"rendered":"

In the midst of another deadly coronavirus\u00a0surge in a pandemic that has already taken more than\u00a0267,000 American lives<\/a>, including\u00a09,134\u00a0in Michigan, there’s hope on the horizon in\u00a0promising\u00a0news about potential COVID-19 vaccines. \"Moderna\u2019s<\/p>\n

<\/div>\n

Massachusetts-based biotech company Moderna applied Monday for\u00a0emergency use authorization from the U.S. Food and Drug Administration for its coronavirus vaccine candidate on\u00a0the heels of more\u00a0encouraging data from late-stage clinical trials that suggest it is 94% effective and prevents severe illness in people with COVID-19.<\/p>\n

Moderna is the second company to request federal approval for a potential coroanvirus vaccine.\u00a0Pfizer \u2014 with its German-based partner BioNTech \u2014 asked regulators for\u00a0emergency use authorization Nov. 20\u00a0for its\u00a0coronavirus vaccine candidate.<\/p>\n

Clinical trials suggest Pfizer’s vaccine\u00a0is\u00a095% effective against COVID-19 beginning 28 days after the first dose.<\/p>\n

How soon can I get a COVID-19 vaccine?<\/strong><\/h3>\n

An FDA advisory committee is expected\u00a0to meet Dec. 17 to review the potential Moderna vaccine’s\u00a0safety and efficacy, the company\u00a0announced Monday. If it’s approved, the first doses of the vaccine could be given as early as Dec. 21, the New York Times reported<\/a>.<\/p>\n

The\u00a0same committee is scheduled to discuss\u00a0<\/a>the Pfizer\u00a0COVID-19 vaccine candidate Dec. 10. Pfizer\u00a0said in a news release that its vaccine\u00a0could be ready for distribution “within hours” of getting\u00a0approval.<\/p>\n

\u201cWe could be seeing both of these vaccines out and getting into people\u2019s arms before Christmas,\u201d Alex Azar, secretary of the U.S. Department of Health and Human Services, said Monday on \u201cCBS This Morning.”<\/a><\/p>\n

But that doesn’t mean most people will\u00a0be able to\u00a0call their\u00a0doctors to\u00a0get a vaccination before the New Year.<\/p>\n

There will be limited supply \u2014\u00a0especially initially \u2014 of any vaccine that gets emergency use authorization. It could be months before there’s enough available for the general public to get immunized.<\/p>\n

\n
\n<\/div>\n

In the midst of another deadly coronavirus surge in a pandemic that has already taken more than\u00a0267,000 American lives<\/a>, including\u00a09,134\u00a0in Michigan, there’s hope on the horizon in\u00a0promising\u00a0news about potential COVID-19 vaccines.<\/p>\n

Massachusetts-based biotech company Moderna applied Monday for\u00a0emergency use authorization from the U.S. Food and Drug Administration for its coronavirus vaccine candidate on\u00a0the heels of more\u00a0encouraging data from late-stage clinical trials that suggest it is 94% effective and prevents severe illness in people with COVID-19.<\/p>\n

Moderna is the second company to request federal approval for a potential coroanvirus vaccine.\u00a0Pfizer \u2014 with its German-based partner BioNTech \u2014 asked regulators for\u00a0emergency use authorization Nov. 20\u00a0for its\u00a0coronavirus vaccine candidate.<\/p>\n

Clinical trials suggest Pfizer’s vaccine\u00a0is\u00a095% effective against COVID-19 beginning 28 days after the first dose.<\/p>\n

How effective are these COVID-19 vaccines?<\/strong><\/h3>\n

Though neither company has published outcomes of its Phase 3 trials,\u00a0early\u00a0data from that research suggests the COVID-19 vaccine candidates\u00a0are very effective.<\/p>\n

In its Phase 3 trial of 30,000 people, Moderna’s vaccine candidate was shown to be 94.1% effective and prevents severe illness in people with COVID-19.<\/p>\n

Of the\u00a0196 coronavirus cases evaluated among the people who took part in the\u00a0trial, 185 were in the placebo group. Additionally, of the 30 people enrolled in the Moderna vaccine trial who had severe cases of COVID-19, all 30 were in the placebo group.<\/p>\n

Clinical trials of Pfizer’s vaccine candidate suggest it is\u00a095% effective against COVID-19 beginning 28 days after the first dose. Of 170 confirmed cases of COVID-19 evaluated in its Phase 3 trials of the Pfizer\u00a0vaccine, the company\u00a0reported\u00a0162 were among people in\u00a0the group that got placebo. Eight cases were identified\u00a0in the group\u00a0that\u00a0received the vaccine.<\/p>\n

Are they safe?<\/strong><\/h3>\n

Though safety reviews continue, so far no serious concerns have been identified for either Pfizer’s or Moderna’s COVID-19 vaccine candidates.<\/p>\n

The most common side effects were\u00a0injection site pain\/redness, fever, fatigue, muscle and joint aches, and headache. Patients in the Moderna trials said the reactions were more pronounced after the second dose of the vaccine.<\/p>\n

There was one COVID-19-related death in the Moderna vaccine study, but the person who died was in the group who received placebo rather than vaccine.<\/strong><\/span><\/p>\n

How many doses of the vaccine will each company produce?\u00a0<\/strong><\/h3>\n

Pfizer says it\u00a0will\u00a0produce\u00a0up to 50 million\u00a0doses of its\u00a0vaccine globally in 2020 and up to 1.3 billion doses by the end of 2021.<\/p>\n

Moderna also is scaling up its global manufacturing with an aim of delivering 500 million to 1 billion doses per year, beginning in 2021.<\/p>\n

While those seem like huge numbers, it’s not\u00a0enough to vaccinate the world’s population of roughly 7.8 billion people, which means doses will be distributed using priorities established by federal and state governments.<\/p>\n

Additionally, both vaccines require two doses per person.<\/p>\n

Who will get\u00a0vaccinated first?<\/strong><\/p>\n

The U.S. Centers for Disease Control and Prevention is working with state public health officials to plan for distribution of\u00a0COVID-19 vaccines.<\/p>\n

The CDC’s\u00a0Advisory Committee on Immunization Practices is planning an emergency session Tuesday to vote on a recommendation that health care providers should be vaccinated first, followed by residents of long-term care facilities, according to a STAT News report.<\/a>\u00a0<\/strong><\/p>\n

The Michigan Department of Health and Human Services drafted a plan<\/a> it submitted to the CDC in October detailing how it would distribute COVID-19 vaccine doses.<\/p>\n

Although\u00a0spokeswoman Lynn Sutfin\u00a0said the plan is still being revised, it\u00a0shows that Michigan health care workers would get vaccinated first.\u00a0Any doses the state\u00a0receives initially would\u00a0be delivered\u00a0to 143 hospitals and health systems for that purpose.<\/p>\n

After that, doses would\u00a0be distributed to 45 local health departments, which would then\u00a0stand up their own clinics to provide vaccines to\u00a0vulnerable populations, including residents of long-term care facilities, first responders,\u00a0and those ages 65 and older who are at highest risk of severe illness with a COVID-19 infection.<\/p>\n

Are there any other COVID-19 vaccines in the works?<\/strong><\/h3>\n

Yes. There are dozens of other coronavirus vaccines in Phase 3 trials worldwide, and several of them are underway in the United States.\"Vials<\/p>\n

Among them are AstraZeneca’s investigational vaccine\u00a0created with researchers at the University of Oxford and its spinoff company, Vaccitech.<\/p>\n

\n
\n<\/div>\n

In the midst of another deadly coronavirus surge in a pandemic that has already taken more than\u00a0267,000 American lives<\/a>, including\u00a09,134\u00a0in Michigan, there’s hope on the horizon in\u00a0promising\u00a0news about potential COVID-19 vaccines.<\/p>\n

Massachusetts-based biotech company Moderna applied Monday for\u00a0emergency use authorization from the U.S. Food and Drug Administration for its coronavirus vaccine candidate on\u00a0the heels of more\u00a0encouraging data from late-stage clinical trials that suggest it is 94% effective and prevents severe illness in people with COVID-19.<\/p>\n

Moderna is the second company to request federal approval for a potential coroanvirus vaccine.\u00a0Pfizer \u2014 with its German-based partner BioNTech \u2014 asked regulators for\u00a0emergency use authorization Nov. 20\u00a0for its\u00a0coronavirus vaccine candidate.<\/p>\n

Clinical trials suggest Pfizer’s vaccine\u00a0is\u00a095% effective against COVID-19 beginning 28 days after the first dose.<\/p>\n

More: <\/strong>Johnson & Johnson CEO says the virus is the only competition in COVID-19 vaccine race<\/a><\/span><\/p>\n

More: <\/strong>Health care workers to get first COVID-19 vaccine doses in Michigan<\/a><\/span><\/p>\n

Although\u00a0spokeswoman Lynn Sutfin\u00a0said the plan is still being revised, it\u00a0shows that Michigan health care workers would get vaccinated first.\u00a0Any doses the state\u00a0receives initially would\u00a0be delivered\u00a0to 143 hospitals and health systems for that purpose.<\/p>\n

After that, doses would\u00a0be distributed to 45 local health departments, which would then\u00a0stand up their own clinics to provide vaccines to\u00a0vulnerable populations, including residents of long-term care facilities, first responders,\u00a0and those ages 65 and older who are at highest risk of severe illness with a COVID-19 infection.<\/p>\n

What are the distribution challenges?<\/strong><\/h3>\n

Both the Pfizer\/BioNTech and Moderna vaccines use brand new technology that’s never before been approved by the FDA. They both use messenger RNA\u00a0and\u00a0must be\u00a0frozen for storage.<\/p>\n

Moderna’s vaccine can be safely stored<\/a> for up to six months at minus 4 degrees Fahrenheit, which is\u00a0regular freezer temperature. It remains stable at standard refrigerator temperatures of 36-46 degrees Fahrenheit for 30 days. And it can\u00a0be kept at room temperature for up to 12 hours, making Moderna’s vaccine easier to store and distribute than Pfizer’s.<\/p>\n

Pfizer’s COVID-19 vaccine candidate is more challenging in that it requires ultra-cold storage of minus 94\u00a0degrees Fahrenheit. It can be stored at 36-46\u00a0degrees Fahrenheit\u00a0for up to 24 hours or at room temperature for no more than two hours after it thaws.<\/p>\n

How will Pfizer ship its ultra-cold vaccines?<\/strong><\/h3>\n

The company developed\u00a0thermal kits containing dry ice<\/strong> that can be used to keep vials of the vaccine ultra cold for up to 15 days of safe storage while they’re shipped.\u00a0Most will come from the company’s Kalamazoo manufacturing site, Pfizer said in a news release<\/a>.<\/p>\n

If the FDA grants emergency use authorization of its vaccine, the company says it will deliver the kits by air to major hubs throughout the country, and then distribute them by ground transport directly to sites where the vaccines will be administered.<\/p>\n

“We will utilize\u00a0GPS-enabled thermal sensors\u00a0with a control tower that will track the location and temperature of each vaccine shipment across their preset routes. These GPS-enabled devices will allow Pfizer to proactively prevent unwanted deviations and act before they happen,” the company said.<\/p>\n

Will Michigan hospitals be able to store\u00a0ultra-cold doses of Pfizer’s vaccines?<\/strong><\/h3>\n

At least 31 hospitals and 11 local health departments now have ultra-cold freezer capabilities<\/strong>, Sutfin said, which is important for longer term storage of the Pfizer vaccine.\u00a0<\/strong><\/p>\n

However, she said, “it is important to note that we expect the vaccine to be given to people very quickly after it is received, and they will be shipped in storage containers with dry ice that can be refreshed and will maintain the appropriate vaccine temperature. Thus, not every entity needs to have an ultra-cold freezer if they are able to receive and get the vaccine administered quickly, which is our expectation.”<\/p>\n

\n
\n

Kristen Jordan Shamus<\/a> \u00a0 |\u00a0Detroit Free Press<\/span><\/h2>\n
\n
\n
<\/div>\n<\/div>\n<\/div>\n<\/div>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

In the midst of another deadly coronavirus\u00a0surge in a pandemic that has already taken more than\u00a0267,000 American lives, including\u00a09,134\u00a0in Michigan, there’s hope on the horizon in\u00a0promising\u00a0news about potential COVID-19 vaccines. Massachusetts-based biotech company Moderna applied Monday for\u00a0emergency use authorization from the U.S. Food and Drug Administration for its coronavirus vaccine candidate on\u00a0the heels of more\u00a0encouraging … <\/p>\n

\u03a3\u03c5\u03bd\u03ad\u03c7\u03b5\u03b9\u03b1 \u03b1\u03bd\u03ac\u03b3\u03bd\u03c9\u03c3\u03b7\u03c2<\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[85],"tags":[90],"class_list":["post-18571","post","type-post","status-publish","format-standard","hentry","category-85","tag-90","item-wrap"],"_links":{"self":[{"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/posts\/18571","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=18571"}],"version-history":[{"count":4,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/posts\/18571\/revisions"}],"predecessor-version":[{"id":18575,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/posts\/18571\/revisions\/18575"}],"wp:attachment":[{"href":"https:\/\/evaggelatos.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=18571"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=18571"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=18571"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}