- Latest updates
J&J vaccine shipping out. Johnson & Johnson began shipping 3.9 million doses of its one-shot vaccine Monday morning after the Centers for Disease Control and Prevention (CDC) recommended the vaccine for distribution over the weekend. CDC’s Advisory Committee on Immunization Practices (ACIP) met Sunday and unanimously voted that the benefits of the new vaccine to combat COVID-19 outweigh any risks. The committee meets again on Monday to discuss the overall implementation of the three vaccines now authorized in the U.S.: the J&J, Pfizer-BioNTech and Moderna products.
- J&J vaccine gets emergency authorization. The U.S. Food and Drug Administration (FDA) Saturday issued an emergency use authorization (EUA) for the one-dose coronavirus vaccine developed by Johnson & Johnson. This vaccine now becomes the third COVID-19 vaccine to be authorized for emergency use in the United States. The J&J product joins the two-dose vaccines developed by Pfizer-BioNTech and Moderna. The J&J vaccine was found to be 66 percent effective in preventing COVID-19 in multi-country clinical trials and 72 percent effective among the U.S. trial participants. It was found to be 86 percent effective in preventing severe illness. Those effectiveness rates are well above the 50 percent threshold the FDA set as necessary for the granting of an EUA but lower than the 94-95 percent efficacy rates of the Pfizer-BioNTech and Moderna products. On Friday, an independent FDA review panel voted unanimously that the benefits of the J&J vaccine outweigh the risks.
- Pfizer storage temperature raised. The U.S. Food and Drug Administration (FDA) gave permission Thursday for the Pfizer-BioNTech vaccine to be moved and stored for two weeks at higher temperatures than had been allowed under the emergency use authorization (EUA) the vaccine received in December. Instead of requiring the vaccine vials to be stored at minus 130 degrees to minus 76 degrees Fahrenheit, the FDA is allowing Pfizer to ship and store the vials at minus 13 degrees to minus 5 degrees Fahrenheit. FDA officials say giving Pfizer permission to maintain its vaccine at higher temperatures will help ease the burden of finding the ultra-low cold storage that has been required for the vaccine and should help get the Pfizer vaccine to more vaccination sites. By comparison, the Moderna vaccine can be shipped and stored at minus 4 degrees.
- Vaccine finder inaugurated: The U.S. public can begin to search for approved COVID-19 providers at vaccinefinder.org, a website where consumers can enter their address or zip code and get a list of vaccine providers and links to where they can schedule a shot. But this service is ramping up slowly. The site so far includes data from 29,000 providers in four states: Alaska, Indiana, Iowa and Tennessee. The site was started at Boston Children’s Hospital, supported by a grant from the federal Centers for Disease Control and Prevention (CDC). If the initial rollout is successful, the site will be expanded to all providers in the nation that are willing to participate.
- Rx executives say more doses are coming. Leaders of pharmaceutical companies that are producing COVID-19 vaccines told a House Energy and Commerce subcommittee on Tuesday that they are ramping up production and distribution of their vaccines or gave the panel a progress report on when they plan to ask the U.S. Food and Drug Administration (FDA) for an emergency use authorization (EUA) for their products. Here are their estimates.
— Pfizer Group President John Young said that shipments of the Pfizer-BioNTech vaccine topped 40 million doses as of Feb. 17 and that the company expects to start sending 13 million doses per week by the middle of March and all 300 million doses the federal government has contracted for by the end of July.
— Moderna President Stephen Hoge said that as of last week, his company had delivered 54 million doses and is on track to have delivered 100 million by the end of March, another 100 million by the end of May and 100 million more by the end of July. Both the Pfizer and Moderna vaccines require two shots.
— Ruud Dobber, an executive vice president at AstraZeneca, said the company has enrolled 30,000 people in its phase 3 clinical trials and expects results “soon.” The federal government has contracted for 300 million doses of this vaccine, should it receive an EUA.
— John Trizzino, executive vice president of Novavax, told the subcommittee that his company has also enrolled 30,000 people in its phase 3 clinical trials and expects to file for authorization from the FDA during the second quarter of this year.
- CDC data show that the vaccines are safe. New data from the CDC reveal that the side effects from COVID-19 vaccines were as expected and not serious among the vast majority of the first 22 million people who received either the Pfizer-BioNTech or the Moderna version. Symptoms most frequently reported were headaches (22.4 percent), fatigue (16.5 percent) and dizziness (16.5 percent). Cases of anaphylaxis allergic reactions were very rare — 4.5 cases per million doses administered. The incidence of side effects was greater for the second dose of the Pfizer vaccine, with nearly 79 percent of recipients saying they didn’t experience any serious symptoms, compared with nearly 94 percent who said they didn’t have any major issues after the first shot. Data was not available for the Moderna vaccine, the second shot of which is not given until 28 days after the first. The data collected was for the first month of vaccinations, from Dec. 14, 2020, to Jan. 13, 2021. CDC Director Rochelle Walensky said at a COVID-19 briefing on Friday that the fact that more people tend to have a stronger reaction to the second shot should not deter Americans from getting the second dose.
- Doses to pharmacies, states expanded. The number of COVID-19 vaccine doses pharmacies will receive from the federal government is being doubled from 1 million each week to two 2 million, Administration officials announced on Wednesday. During the first stage of the partnership between the federal government and pharmacies across the country, 6,500 drug stores are slated to get the vaccine, with that number expected to eventually increase to 40,000 national chain stores, independent drugstores and pharmacies located inside grocery stores. States are continuing to control which populations are eligible for the vaccines, although the administration has urged them to begin vaccinating residents over age 65, which about half the states are doing. The administration has also increased the amount of vaccine being delivered to states. States will now get 13.5 million doses each week. Officials also announced that on average, 1.7 million Americans are receiving a COVID-19 vaccine each day.
- Government orders more vaccine. The federal government has ordered 200 million more doses of COVID-19 vaccines — 100 million each from Pfizer-BioNTech and Moderna. That will bring to 600 million the number of doses that will be delivered by the end of July. Because both of these vaccines require two doses, that would fully vaccinate 300 million Americans. State officials across the country have said they need more vaccine in order to meet their needs.
- Quarantine rules eased for the vaccinated. The CDC now says that people who have received both doses of either the Pfizer-BioNTech or Moderna vaccine will no longer be required to quarantine after they are exposed to someone with COVID-19. According to CDC guidance, the easing of quarantine guidelines applies to people two weeks after they are fully vaccinated, are within three months of having received their last dose and have remained symptom free. The CDC stresses that vaccinated persons should continue to follow recommendations for preventing the spread of the virus, including wearing a mask, staying at least 6 feet away from others, avoiding crowds and poorly ventilated spaces, and washing their hands often.
- Vaccine acceptance increases. A CDC study shows that the willingness of Americans to receive a COVID-19 vaccine continues to increase, especially among adults over age 65. According to the new data, the percentage of people who say they are willing — or somewhat willing — to get vaccinated increased from 62 percent in September to 68 percent in December. Among adults 65 and older, 66 percent said in December that they would likely be vaccinated compared with 42 percent of adults ages 18 to 64 who said that. The percentage of people who say they do not intend to get vaccinated continues to decline — from 38 percent in September 2020 to 32 percent in December. The main reasons people give for their vaccine hesitancy are concerns about side effects and safety (30 percent), they plan to wait to see if the vaccines prove safe (14.5 percent), they don’t trust government (12.5 percent), and concern that the vaccines were developed too quickly (10.4 percent).
- The COVID-19 vaccine developed by AstraZeneca and the University of Oxford may be the first such vaccine that preliminary data shows could slow the transmission of the virus, according to a new report by Oxford researchers. The paper, which has not yet been peer reviewed, is based on weekly nasal swabs taken to see if there were signs of the virus in people participating in clinical trials in 2020. The researchers said they found a 67 percent reduction in evidence of the virus on those swabs among those who had received the AstraZeneca vaccine. The data was gleaned from clinical trials in the United Kingdom, Brazil and South Africa. AstraZeneca is still completing its U.S. trial and is expected to release data from that study later this month. AstraZeneca is not conducting weekly swab tests on U.S. trial participants, a company executive told the Wall Street Journal. The only two COVID-19 vaccines authorized for use in the U.S., from Pfizer-BioNTech and Moderna, have been shown in clinical trials to be highly effective in preventing illness, but it has yet to be determined if they prevent infection and transmission of the coronavirus to others.
- Pace of vaccination in nursing homes. At least three-quarters of residents in most U.S. skilled nursing facilities had received at least one dose of a COVID-19 vaccine — a median of 77.8 percent across 11,460 facilities — during the first month of the vaccination rollout (Dec. 18 – Jan. 17). That’s according to a new CDC report, which also found that a median of 38 percent of staff members had received the vaccine by that date. The CDC has been working with pharmacies to administer vaccinations at these facilities, where residents have been hit disproportionately hard by the pandemic — accounting for 38 percent of COVID-19-related deaths in the U.S.
- Second dose timing. The second dose of either the Pfizer-BioNTech or Moderna vaccine may be scheduled for up to six weeks after the first shot, according to an update posted by the CDC. When the FDA authorized the two vaccines for emergency use late last year, it said that the second dose of the Pfizer vaccine should be administered in 21 days while the Moderna protocol is for the second shot to be given in 28 days. CDC still says that while the “second dose should be administered as close to the recommended interval as possible,” if that is not feasible the second dose can be received up to 42 days after the first one.
- Some allergic reactions reported. The CDC has advised Americans that it has documented more cases of severe allergic reactions among people receiving a COVID-19 vaccine. Among 1.8 million getting their first dose of either the Pfizer-BioNTech or Moderna vaccines, 21 had a reaction known as anaphylaxis. According to the CDC, these reactions can be quickly dealt with and all 21 patients have recovered. The rate of these reactions is about 10 times that of people who get a flu shot, say CDC officials, who stress that these episodes are still exceedingly rare. The agency continues to recommend that anyone who has ever had a severe allergic reaction to any of the ingredients in a COVID-19 vaccine abstain from getting it. If you have a history of severe allergic reactions to other vaccines, ask your doctor if you should get a COVID-19 vaccine. Common side effects — including injection-site pain, fatigue, headache, muscle pain, chills, joint pain and fever — have been common in both vaccines and should not be cause for concern, experts say. If you have an adverse reaction, report it through the federal Vaccine Adverse Event Reporting System (VAERS) online.
- Vaccines and underlying health conditions. The CDC has issued guidance for those with underlying health conditions, saying they can receive the COVID-19 vaccine as long as they have not had a severe allergic reaction to any of the ingredients in the vaccine. The CDC had additional comments for people in the following groups:
- People with HIV or who have weakened immune systems can receive the vaccine, but they should be aware that safety data is limited, the CDC said. They should also be aware of the potential for reduced immune responses to the vaccine.
- People who have autoimmune conditions can receive the vaccine, but they should be aware that there is no data yet on the safety of the vaccines for them.
- People who have previously had Guillain-Barré syndrome can receive the vaccine. The CDC noted that to date, no cases of Guillain-Barré syndrome have been reported following vaccination.
- People who have previously had Bell’s palsy can receive the vaccine. Even though cases of Bell’s palsy were reported in trial participants, the FDA “does not consider these to be above the rate expected in the general population,” the CDC said. “They have not concluded these cases were caused by vaccination.”
Researchers around the world have been working at record speed to develop vaccines to combat COVID-19. Less than a year after the start of the pandemic, that goal is now a reality. The U.S. is among the countries that have begun vaccinating people against a virus that has so far infected more than 25 million people in the United States; it’s killed more than 421,000 Americans and more than 2.1 million people globally. As noted above, two vaccines, one from Moderna and another from Pfizer-BioNTech, are now being distributed in the U.S., first to health care workers and staff and residents of long-term care facilities, next to people 65 and older and frontline essential workers.
Both vaccines received an emergency use authorization (EUA) from the FDA. An EUA is a green light, of sorts. It is not the same as official approval.
During a public health emergency, such as the coronavirus pandemic, the FDA can authorize in a timely manner previously unapproved medical products to diagnose, treat or prevent the illness of concern when there are no other approved or available alternatives. The EUA process is faster than standard FDA approval, which can take six to 10 months. However, data proving safety and effectiveness are still required for authorization, and the FDA and an advisory committee of experts use this data to weigh the risks and benefits of the product in question.
What, exactly, is a vaccine?
A vaccine is something that helps a person build up immunity to an infectious disease. It works by intentionally introducing the body to an inactive form of a disease-causing germ, or something similar to it. This then stimulates the immune system’s production of antibodies, the proteins that help to protect the person from a future infection if he ever comes across the real germ.
Think of it like a workout for your immune system: You’re “sending it to the gym and preparing it to be able to do something when it encounters the real thing in the future,” says Tony Moody, associate professor of pediatrics and immunology at Duke University School of Medicine and a principal investigator at the Duke Human Vaccine Institute. “Essentially, what a vaccine is doing is teaching the immune system how to handle something before you actually encounter the real thing — so that, hopefully, when you do encounter the real thing, you’re able to deal with it quickly and get rid of it.”
In the case of the new coronavirus, a vaccine makes a person resistant to an infection from the virus and the illness it causes — COVID-19 — or, at least, enables a person who becomes infected to have “a shorter course [of disease] or not as many complications,” Moody adds.
What coronavirus vaccines are available now?
The three vaccines that have received EUAs – Pfizer-BioNTech, Moderna and Johnson&Johnson – are so far the only products available to Americans.
Pfizer’s vaccine was given emergency authorization by the FDA for use in people 16-years-old and older, making it the first coronavirus vaccine available to the American public.
Moderna and J&J’s vaccines have now been authorized for people 18 and older.
The three vaccines have been found to be highly effective at preventing COVID-19 in clinical trial participants. Pfizer-BioNTech’s two-dose vaccine is about 95 percent effective against COVID-19, regardless of age, race or other risks for severe illness from an infection, an FDA analysis shows. And Moderna’s proved to be about 94.5 percent effective against COVID-19 in people of all ages, genders and ethnicities. J&J’s product has been found to be 66 percent effective overall and 72 percent effective in the United States.
Are the vaccines safe?
Safety is a key concern among health officials and experts. Participants in the Pfizer-BioNTech, Moderna and Johnson&Johnson trials experienced side effects after vaccination, including injection-site pain, fever, chills, headaches, muscle aches and joint pain. These symptoms are temporary and are in line with side effects some people experience from other vaccines, including the flu shot and the vaccine to prevent shingles.
The CDC has documented several cases of anaphylaxis in U.S. vaccine recipients. Though an anaphylactic reaction is potentially life-threatening, it can be quickly halted as it was in these six cases, with medicines such as epinephrine. Because of this, the CDC is recommending that anyone who has ever had a severe allergic reaction to any ingredient in a COVID-19 vaccine abstain from receiving it. If you have a history of severe allergic reactions to other vaccines, ask your doctor if you should get a COVID-19 vaccine, the agency advises.
After a vaccine is authorized, many vaccine safety monitoring systems watch for adverse events, according to the CDC. If one is discovered, “experts quickly study it further to assess whether it is a true safety concern” and then adjust vaccine recommendations as needed, the agency explains.
How are the vaccines being distributed?
The federal government is overseeing the distribution and tracking of coronavirus vaccines in the U.S., but state and local officials are prioritizing who gets the vaccine in their jurisdictions. The government is also partnering with private companies to ensure high-risk individuals can easily access a vaccine. Health care workers and residents and staff of long-term care facilities were in the first group targeted for vaccination; the CDC recommends that the next group of Americans to receive a COVID vaccine should be adults age 75 and older. However, many states prioritized all adults age 65 and older after the federal government directed states to expand distribution in order to get the vaccine out faster. The next group for vaccination under CDC guidelines would be frontline workers, including first responders, postal workers, teachers, public transit workers and people who work in grocery stores.
Officials predict it will take several more months to vaccinate everyone who wants a vaccine, even as production ramps up and more vaccine candidates clear authorization.
There are logistical considerations, including the need to ensure proper transportation and storage for the vaccines. Both the Pfizer and the Moderna vaccines require cold storage at specific temperatures but the J&J vaccine is able to be shipped and stored at conventional refrigeration temperatures.
How much does the vaccine cost?
The federal government pre-purchased hundreds of millions of vaccine doses with taxpayer money, and Americans will not have to pay to receive them.
Vaccine providers are able to charge an administration fee for giving the shot, but this fee should be covered by public or private insurance, or by a government relief fund for the uninsured.
Can I still get COVID-19 after getting the vaccine?
It’s unclear whether someone who’s been vaccinated can still become sick with COVID-19 and how long immunity will last, although more details on the vaccine’s effectiveness should emerge in post-trial surveillance.
“That’s something that the recipients will have to understand when they get the vaccine,” says William Schaffner, an infectious disease specialist and professor of preventive medicine at the Vanderbilt University School of Medicine. “The vaccine provides protection, but it won’t be like a suit of armor.”
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