How Has Development Been Sped Up Amid The Pandemic
Under normal circumstances, during which the stages of vaccine development occur sequentially, a vaccine takes eight to fifteen years on average to get from the lab into the hands of health-care providers. The fastest a vaccine had ever been developed before this pandemic was four years. Following the emergence of COVID-19, however, researchers around the globe accelerated the process by carrying out stages of development simultaneously and by looking to new vaccine technologies. What were seeing is remarkable, says Paul Offit, director of the Vaccine Education Center at the Childrens Hospital of Philadelphia. It is a scientific tour de force.
The U.S. Operation Warp Speed timeline hinged on overlapping stages of development mass production started for strong candidates even while clinical trials were ongoing. Before their vaccines were approved, Moderna received $2.5 billion in a deal under Warp Speed that included the purchase of one hundred million doses, while Pfizer and BioNTech signed a $1.95 billion contract to manufacture and distribute one hundred million doses of their vaccine. Since President Joe Biden took office, his administration has purchased over a billion additional doses, the vast majority of which are to be donated to other countries as part of his goal to get 70 percent of the world vaccinated by late 2022.
First Us Rollouts Of Doses Could Start In December With Health
U.S. officials estimate the initial supply of Covid-19 vaccines immediately after authorization at about 6.4 million doses.
Pfizer Inc. PFE0.34% and its partner,BioNTech SE, BNTX 2.36% have asked the U.S. Food and Drug Administration to authorize use of their coronavirus vaccine, and an FDA decision could come as soon as this weekend.Moderna Inc. MRNA 1.83% has made a similar request for its shot, and other vaccines could follow. The first rollouts could begin within days.
Here is what we know and dont know about how, and when, the vaccine will get to you.
How will the Covid-19 vaccines be approved, and who decides who will get them?
The FDA will determine whether to authorize Covid-19 vaccines for use. An FDA advisory committee of outside experts voted Thursday in favor of Pfizers request for authorization of its vaccine. The FDA is expected to decide imminently.
The FDA has scheduled a Dec. 17 advisory committee meeting to consider Modernas request for authorization. A separate advisory committee to the U.S. Centers for Disease Control and Prevention has voted to recommend that health workers and residents of nursing homes and other long-term care facilities be first in line for the limited number of doses. The same committee will hold additional votes on which groups should be next in line. But governors can make the final call within their states.
How will the vaccines be distributed?
What logistics are in place to deliver the vaccines?
Yes.
Can The Vaccines Affect My Fertility
There is zero evidence that COVID vaccines affect fertility. The vaccines tell the body how to fight the protein that is on the outside of the coronavirus, but this protein is completely different from the protein that allows for successful reproduction. The antibodies your body produces to fight the coronavirus will not attack reproductive proteins.
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Now Vaccinating: All Individuals 6 Months+
Q Will Youth With High
A. Everyone 5 years of age and older is now recommended to get a COVID-19 vaccination. If you have questions about getting a COVID-19 vaccine, talk to your health care provider for advice. Clinical trials for children younger than 5 years of age are ongoing to determine if the existing vaccines are safe and effective for them.
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Future Rounds In Early 2021
Once medical professionals get the vaccine, officials must determine which essential workers will get the vaccine next.
California officials have not determined the order of vaccinations for other essential industries. Trade groups and labor unions are actively lobbying for earlier slots for their members working in law enforcement, agriculture, meatpacking, dentistry, child care, schooling and many other sectors.
Theres a lot of haziness about how you would define an essential worker, Simon said. Thats a very broad group.
There has also been a push to get the vaccine to people with health conditions that make them especially vulnerable.
Some county leaders have advocated for prioritizing people in jail, where the virus can spread quickly in crowded conditions. They also expressed concerns about ensuring that communities of color have equitable access to the vaccine. Early in the pandemic, when the county first set up its COVID-19 testing sites, those communities did not have adequate access to testing in some cases none even as their residents were being hardest hit by the virus.
County Supervisor Hilda Solis has suggested the county use libraries, clinics and other community sites for vaccinations. Supervisor Janice Hahn asked the county to explore schools as vaccination sites, which L.A. schools Supt. Austin Beutner supports.
Ferrer said in a recent report that, at least at first, using schools as vaccination sites might not be doable.
Q What Have The Trials Revealed
A. Through their respective clinical trials, Pfizer-BioNTech and Moderna have indicated their vaccines are approximately 95% effective. The pediatric Pfizer-BioNTech vaccine was found to be almost 91% effective in clinical trials. The J& J vaccine was found to be more than 74% effective.
Information gathered through clinical trials becomes public in the course of the EUA submission. Once the EUA is submitted, these documents become accessible by the public through the FDA.
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Q: What Can You Do Once You Are Fully Vaccinated
A: If you have been fully vaccinated and two weeks have passed since either your second dose of Pfizer-BioNTech or Moderna vaccines or the single dose J& J vaccine, you can:
- Gather indoors in private locations with fully vaccinated people without wearing a mask or staying 6 feet apart.
- Gather indoors inside a home or private setting without a mask or staying 6 feet apart with one household of unvaccinated people who are not at risk for severe illness from COVID-19 .
- Travel in the United States and you do not need to get tested before or after travel or self-quarantine after travel.
You should still get tested if youve had close contact with someone who has COVID-19 or if you have symptoms of COVID-19.
- If you live in a group setting and are around someone who has COVID-19, you should still stay away from others for 14 days and get tested, even if you dont have symptoms.
If traveling internationally, you need to pay close attention to the situation at your international destination.
- You do NOT need to get tested before leaving the United States unless your destination requires it.
- You still need to show a negative test result or documentation of recovery from COVID-19 before boarding a flight to the United States.
- You should still get tested 3-5 days after international travel.
- You do NOT need to self-quarantine after arriving in the United States.
A Guide To Global Covid
- Governments, multilateral organizations, and private firms have spent billions of dollars to develop effective vaccines for COVID-19.
- More than two dozen vaccines are already being distributed, though highly effective mRNA vaccines have become the most sought-after worldwide.
- Vaccines go through rigorous testing for safety and effectiveness before they are approved for public use.
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Us Officials Say Covid
U.S. officials say the nations first COVID-19 vaccine will begin arriving in states Monday morning, three days after FDA emergency approval.
You can do the math and see we wont get beyond that high-risk group even with the initial allotments we are supposed to receive, said UCLA epidemiologist Dr. Timothy Brewer.
Dr. Robert Schechter, a California Department of Public Health medical officer, told a vaccine advisory panel Wednesday that the initial 327,000 doses are likely to end up largely in hospital settings. If the FDA provides emergency authorization for Modernas vaccine soon, California could receive 2 million or more doses of the two vaccines by the end of the month, and then followed by more, Schechter said.
Los Angeles County expects to receive about 84,000 vaccine doses early next week, said Dr. Paul Simon, chief science officer for the county Department of Public Health. The doses will be shipped from Pfizer to nine medical facilities with ultra-cold freezers that can keep the Pfizer doses at the required temperature of minus-70 degrees Celsius.
From there, the doses will be distributed to 83 acute-care hospitals, Simon said. Not all employees at those hospitals will receive immunizations in the first shipment, L.A. County Public Health Director Barbara Ferrer told county officials earlier this week.
The supply of vaccine is expected to be limited, while the need will be high, she said.
What Is The Status Of Covid
More on:
More than thirty vaccines have been approved for general or emergency use in countries around the world. As of mid-2022, over twelve billion doses had been administered worldwide. In dozens of countries, at least three-quarters of the population has been fully vaccinated Qatar, Singapore, and the United Arab Emirates are among those with the highest immunization rates. However, many othersmostly in Africahave vaccinated only small fractions of their populations. One-third of the global population is yet to receive a vaccine dose.
To keep up progress, many countries implemented vaccination mandates. For example, Italy and Saudi Arabia mandated COVID-19 vaccinations for both government and private-sector workers. The United States did the same for its public sector and large private employers, but courts blocked both mandates, and legal challenges are ongoing. Other countries have enacted mandates for health-care workers only. At the same time, childrens access to COVID-19 vaccines is gradually expanding: in China, children aged three and above can be vaccinated, and in the United States, children as young as six months old are eligible.
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Stages Of Vaccine Development And Testing
In the United States, vaccine development and testing follow a standard set of steps. The first stages are exploratory in nature. Regulation and oversight increase as the candidate vaccine makes its way through the process.
First Steps: Laboratory and Animal Studies
Exploratory Stage
This stage involves basic laboratory research and often lasts 2-4 years. Federally funded academic and governmental scientists identify natural or synthetic antigens that could help prevent or treat a disease. These antigens could include virus-like particles, weakened viruses or bacteria, weakened bacterial toxins, or other substances derived from pathogens.
Pre-Clinical Stage
Pre-clinical studies use tissue-culture or cell-culture systems and animal testing to assess the safety of the candidate vaccine and its immunogenicity, or ability to provoke an immune response. Animal subjects may include mice and monkeys. These studies give researchers an idea of the cellular responses they might expect in humans. They may also suggest a safe starting dose for the next phase of research, as well as a safe method of administering the vaccine.
Researchers may adapt the candidate vaccine during the pre-clinical state to try to make it more effective. They may also do challenge studies with the animals, meaning they vaccinate the animals and then try to infect them with the target pathogen.
IND Application
Once the IND application has been approved, the vaccine is subject to three phases of testing.
VAERS
Children 6 Months To 4
Children 6 months to 4 are eligible for the Moderna COVID-19 vaccine.The National Advisory Committee on Immunization recommends 8 weeks between a first and second dose of the COVID-19 vaccine.
Children who receive their first dose before they are 5 and their second dose when they are 5 will receive the Moderna vaccine for both doses.
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What You Need To Know
- COVID-19 vaccines are available for everyone ages 6 months and older at no cost.
- Vaccines were paid for with taxpayer dollars and will be given free of charge to all people living in the United States, regardless of insurance or immigration status.
- COVID-19 vaccination is an important tool to help stop the pandemic.
- CDC recommends you get a COVID-19 vaccine as soon as you can.
Will Masterlisting Be Done Online How Will Those Without Access To The Internet Be Included
Health facilities and LGUs may submit required data online through VIMS-IR, any information system linked to VIMS-IR, or physical forms for areas without connectivity. The forms are to be consolidated by the Human Resource Office of the facility and submitted to LGUs for encoding and submission to CHDs.
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How Is A Vaccine Developed
There are many stages involved in the development and production of a vaccine, from initial academic research to distribution to hospitals and doctors offices.
Clinical trials are crucial indicators of whether a vaccine is effective. Potential vaccines, as with other drugs, are commonly tested in animals first. Human trials are broken up into three phases, progressively increasing the number of volunteers. If a vaccine candidate appears to be ineffective, has harmful side effects, or is too similar to existing vaccines, it wont move on. Trials are often carried out blind, by which some groups are administered the vaccine and some receive a placebo.
If a vaccine candidate is considered successful in human trials, the developers can seek approval by a national or regional regulatory agency, such as the FDA or the European Medicines Agency. In the United States, less than 10 percent of all drugs that go into clinical trials make it past this part of the process. Prior to approval, a vaccine maker can ask the FDA for an emergency use authorization , which allows the sale of unapproved medical products. Finally, the vaccine must be approved by national regulators in other countries to be distributed abroad. Following approval, the vaccine can be manufactured for broad use. In August 2021, the FDA granted approval to the Pfizer-BioNTech vaccine, the first to receive a license in the United States. Modernas vaccine was approved the following January.
Answers To Key Questions About Covid
To help answer common vaccine questions, we consulted Dr. Stanley Perlman, a professor at the University of Iowas Carver College of Medicine and a member of the U.S. Food and Drug Administrations vaccine advisory committee, and Angela Shen, a visiting scientist with the Vaccine Education Center at Childrens Hospital of Philadelphia.
When can I get a vaccine?
Now, if you’re at least 12 years old.
All three vaccines are widely available for anyone over 18, and the U.S. Food and Drug Administration said kids ages 12 to 18 can get Pfizer-BioNTech’s shot.
Where are COVID-19 vaccines available?
COVID-19 vaccines are now available in a variety of locations, including pharmacies, hospitals and public clinics. To find an appointment in your area, you can search VaccineFinder.org, which collects data directly from government agencies.
How much does it cost to get vaccinated?
Nothing for the vaccine itself. The federal Operation Warp Speed program funded vaccine development with the intent that they be offered free to all Americans, regardless of insurance status.
The caveat: The facility where you get the vaccine may choose to charge something like an administrative fee.
Can I choose which vaccine I get?
Probably. Vaccine supply is now good enough that many clinics stock different types and allow people to choose which one they want.
What are the differences between the shots?
Can pregnant people get the vaccine?
Can kids get the vaccine?
Can kids get the vaccine?
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Should I Take Any Available Dose Even If Im Not Eligible For The Vaccine Yet
Some people have been lucky enough to receive the COVID-19 vaccine early, despite not qualifying for an eligible group in their area. If you happen to have the chance to receive the vaccine earlywithout fabricating your eligibilityyou should feel confident taking it.
Its not morally wrong at all, but only if its an excess dose thats going to be wasted, Dr. Thomas explains. Its better overall to take the vaccine and contribute to community immunity than to allow a precious resource to be thrown away.
This is not the same as skipping the line. At the end of each day, a few extra doses from open vials will be available due to no-shows. Often, Dr. Thomas explains, people who accompany those being vaccinated are offered a leftover dose. No matter how you get the chanceas long as the vaccine is expiring and wouldnt otherwise go to someone in a prioritized groupyou can and should keep it from going to waste.
Q What Happens If I Refuse To Get Vaccinated
A. There are no legal repercussions for refusing the vaccine. If you do not get vaccinated, you will not be protected against the virus that causes COVID-19 and will be more likely to be infected with the virus. Additionally, you will be at risk of transmitting this deadly virus to loved ones and other community members.
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Q: Can I Get More Than One Vaccine
A: Current CDC guidance states that the Pfizer-BioNTech, Moderna, and J& J vaccines should not be mixed for the primary series. While, CDCs clinical guidance advises people to get the same booster as their initial vaccine, it allows people to mix and match if they have a different preference for a booster. Mixing and matching COVID-19 vaccines refers to getting a different COVID-19 booster than the initial vaccine . People who are eligible can get a booster shot with any available COVID-19 vaccine, regardless of whether they received the J& J, Moderna, or Pfizer-BioNTech vaccine for their initial dose.