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Tag: FDA - Organic Lifestyle MagazineTag: FDA - Organic Lifestyle Magazine
FDA Approves Emergency Authorization of Pfizer Vaccine for Children 5-11
On Friday, October 29th the FDA approved the Pfizer Covid-19 vaccine for emergency authorization for children ages 5-11.
The long-term risks to children are not known in an emergency authorization trial.
Children receiving the vaccine will get two shots three weeks apart with a lower dose of the vaccine than those 12 and older.
“We’re never gonna learn about how safe the vaccine is until we start giving it.”
On August 23rd the FDA approved the Pfizer biotech vaccine. The vaccine is approved for Covid prevention for those 16 and older but is still authorized for emergency use for children 12-15. The vaccine is also authorized for emergency use of a third dose for those who are immunocompromised.
The vaccine was originally authorized for emergency use on December 11th, 2020 for those 16 and older, and was authorized on May 10th, 2021 for children 12 and up.
The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “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.
Not only have the Covid-19 vaccines been developed faster than any other vaccine, the Pfizer vaccine has been FDA-approved faster than any other vaccine.
Johnson & Johnson Covid Vaccine Linked to Neurological Disorder
The FDA has added a warning of an increased risk to Guillain-Barre syndrome following the Johnson & Johnson Covid-19 vaccine.
Guillain-Barre syndrome is a rare neurological disorder that causes nerve damage and can result in paralysis.
Based on an analysis of Vaccine Adverse Event Reporting (VAERS) data, there have been 100 preliminary reports following vaccination with the Janssen vaccine after approximately 12.5 million doses administered.
The cases of Guillain-Barre syndrome typically occurred two weeks after vaccination in males 50 and older, said the CDC.
The rate of reported cases of Guillain-Barre currently exceeds the “background rate” or the number of cases reported before the COVID-19 vaccine was introduced.
The syndrome is also a side effect of other vaccines like shingles and the flu.
The AstraZeneca vaccine has also been linked to cases of Guillain-Barre syndrome.
Dr. Anthony Fauci has agreed with Gottlieb’s statements, saying “What I believe… the country is going to be hearing soon if updated guidelines from the CDC”. President Biden is expected to announce new CDC guidelines as early as this week. The CDC currently says the following about masks outdoors:
Masks may not be necessary when you are outside by yourself away from others, or with people who live in your household. However, some areas may have mask mandates while out in public, so please check the rules in your local area (such as in your city, county, or state). Additionally, check whether any
Current coronavirus infection rates are down 14% from one week ago. The risk of transmitting coronavirus outdoors is extremely low. Additionally, vitamin D has been shown to help prevent the coronavirus, so the more fresh air we can all get, the better.
The Coronavirus Vaccine
The first non-trial dose of the coronavirus vaccine was administered earlier this week in the U.K, to a 90-year-old woman. Two of the first health care workers in the U.K have had severe allergic reactions to the vaccine. Pfizer has urged those with serious allergies not to get the vaccine.
The FDA has approved the coronavirus vaccine, and the first doses were administered yesterday (Monday, December 14th).
Pfizer was the first company to be approved by the FDA, Moderna with likely be next. Other companies such as Johnson and Johnson also have vaccine trials in the late stages.
More than nine in 10 people immunized with Moderna’s coronavirus vaccine candidate registered some level of side effects.
Most people are reporting some side effects. Common complaints include headache, fatigue, chills, muscle soreness, fever, and joint pain as well as general flu-like symptoms.
The most common reactions with Pfizer’s vaccine were pain at injection site (84%), fatigue (63%), headache (55%), muscle pain (38%), chills (32%), joint pain (24%), and fever (14%).
“Systemic events (fatigue, headache, chills, muscle pain and joint paint) were reported in small numbers of younger recipients of [the second shot],” Pfizer said in a report published in The New England Journal of Medicine. “But no severe systemic events were reported by older recipients of this vaccine candidate.”
The data gathered has shown that you are even more likely to experience side effects after the second dose of the vaccine. The vaccine requires two doses over the course of a couple of weeks.
The vaccine has not yet been approved for pregnant women or children under the age of 16.
Currently, the U.S is planning to receive 100 million doses of the vaccine, enough for 50 million people. The Trump administration allegedly turned down an additional 100 million doses of the vaccine. Pfizer has said that they may not have extra doses available until mid-summer.
If you are worried about contracting or spreading the coronavirus, we recommend prioritizing gut health above all else and building a strong immune system.
FDA Updates COVID-19 Vaccine Safety Guidelines
The Food and Drug Administration (FDA) has released updated safety guidelines for coronavirus vaccine makers that would make it impossible for a vaccine to be ready by election day. The FDA now says that vaccine manufacturers need to follow vaccine trial participants for two months to monitor side effects before seeking emergency approval.
Data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile, including: adverse events; cases of severe COVID-19 disease among study subjects; and cases of COVID-19 occurring during the timeframe when adaptive (rather than innate) and memory immune responses to the vaccine would be responsible for a protective effect.
President Trump has continued to insist that a vaccine will be ready before elections on November 3rd, and the administration had tried to block the FDA from formally publishing these safety guidelines. The FDA has been communicating these guidelines to the public and vaccine manufacturers informally.
Seven former FDA commissioners released an op-ed in the Washington Post that criticized President Trump’s handling of the COVID-19 vaccine process.
But a safe and effective vaccine will not be enough; people will also have to choose to take it. This depends on widespread confidence that the vaccine approval was based on sound science and not politics. If the White House takes the unprecedented step of trying to tip the scales on how safety and benefits will be judged, the impact on public trust will render an effective vaccine much less so.”
Two of the commissioners responsible for this statement, Scott Gottlieb and Mark McClellan, are on the boards of two of the companies with a coronavirus vaccine in development, Pfizer and Johnson & Johnson respectively.
FDA Acknowledges Amalgam Fillings Potential Harm for Pregnant Women & Children
The United States Food and Drug Administration (FDA) has updated guidelines for dental amalgams:
Dental amalgam fillings may release small amounts of mercury in the form of a vapor (gas), depending on the number and age of existing fillings, and actions such as tooth grinding and gum chewing. When a new amalgam filling is placed or an old filling is removed, patients and healthcare providers may experience a temporary increase in exposure to mercury vapor. While there are no known health risks associated with ingestion (swallowing) of small particles of dental amalgam, inhaling (breathing in) mercury vapors may be harmful in certain patients.
In general, people with multiple dental amalgam fillings may have slightly higher mercury levels in their blood or urine, however, they usually remain at a level considered safe. Studies on people with dental amalgam do not show conclusive evidence that dental amalgam causes harmful health effects in the general population.
The FDA goes on to state that certain people, “including women who are pregnant or who are planning to become pregnant, nursing mothers, children (especially those under the age of six), people with a known allergy to mercury, and people with a neurological impairment or kidney dysfunction,” could be more susceptible to damage caused by dental amalgam. They recommend thatanyone who is of the “high-risk populations identified” should avoid dental amalgam “if possible and appropriate.”