Hope on the Horizon

The FDA Authorizes the Johnson & Johnson Vaccine for Emergency Use

The third vaccine to be authorized since December, this shot requires only one dose.

By Catherine Wendlandt February 24, 2021

Updated 7:45 p.m. Feb 27

On Saturday the Food and Drug Administration approved Johnson & Johnson's Covid-19 vaccine for emergency use, making it the third vaccine to be authorized in the U.S. 

This vaccine is about 66 percent effective in preventing moderate-to-severe cases of Covid-19 and 85 percent effective in preventing the worst cases. While that's a lower efficacy than with Moderna's and Pfizer's vaccines, the advantage of Johnson & Johnson's shot is that it is only one dose, plus it does not have to be kept at as cold a temperature as the other two. 

Another difference is in how this vaccine is made. The Moderna and Pfizer vaccines uses messenger RNA to give your cells a genetic code to make a spike protein that looks to your body like the coronavirus, and your immune system attacks it, making antibodies. The mRNA is very fragile, which is why it must be kept at such cool temperatures. According to a report from the Associated Press, the Johnson & Johnson vaccine uses a Trojan horse method: the necessary spike proteins are snuck into your body through a cold virus, and your body starts making copies of that protein, so your immune system can start making antibodies. This technology is similar to that of other Covid-19 vaccines in development, like AstraZeneca's, according to the report, as well as the tech used to make an Ebola vaccine. 

The Johnson & Johnson vaccine is approved for people age 18 and older, just like Moderna's vaccine. According to PBS News Hour, the company hopes to make 20 million doses by the end of March and 100 million by the end of June. 

Want to know more about this new vaccine? Check out the FDA's fact sheet.

Updated 12:21 p.m. Feb 24 

A third Covid-19 vaccine may soon be available. Today, the Food and Drug Administration released a report that found Johnson & Johnson's vaccine to be safe and effective against the virus. 

The vaccine was submitted for emergency-use authorization on February 4. Before that, Johnson & Johnson conducted trials with about 40,000 people across the United States, South Africa, and Latin America. According to the FDA's report, the vaccine is about 66 percent effective in preventing moderate-to-severe Covid-19, and efficacy is similar across population subgroups like age, comorbidity, race, and ethnicity.

While the efficacy of the Johnson & Johnson vaccine is less demonstrative than of Moderna's and Pfizer's, this new vaccine does have a few advantages in its pocket. First, it only requires one dose as opposed to two, and it doesn't have to be refrigerated. Considering some vaccination centers were rushing to administer vaccines last week during the power outages, this could be a very good thing. 

However, the vaccine is not approved just yet. An advisory board will debate the vaccine this Friday and make an official recommendation; from there, the FDA will decide whether to authorize it for emergency use. 

Although last week's storm temporarily halted shipments to the state, 3,146,940 Texans have received their first Covid-19 vaccine, and 1,422,169 have received their second dose, according to the Texas Department of State Health Services. In Harris County, 443,823 first doses have been administered and 213,330 people have been fully vaccinated.

Updated 9:19 p.m. Dec 18

The Food and Drug Administration Friday approved Moderna's Covid-19 vaccine for emergency use on adults age 18 and older. This decision comes exactly a week after the FDA approved Pfizer's vaccine, which can be used adults and teens age 16 and older and was distributed across the country earlier this week. 

“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen Hahn in a statement. 

Read the full statement here.

Updated 6:15 p.m. Dec 14 

Last Friday, the U.S. Food and Drug Administration approved the Pfizer-BioNTech Covid-19 vaccine for adults and teen age 16 and older. This morning, MD Anderson Cancer Center received Houston’s first shipment of vaccines. Tomorrow, more hospitals, including Houston Methodist, the TMC, CHI St. Luke’s, Texas Children’s Hospital Main, Lyndon B. Johnson Hospital, and Memorial Hermann, will receive shipments.

Turner encouraged these hospitals to “start putting those vaccines to use as quickly as possible.” Front line workers will be among the first to get vaccinated. 

The mayor also encouraged the TMC to be transparent and show the public healthcare workers physically taking the vaccine, similar to what New York has done. “I think it would create more confidence, and make people feel better,” said Turner. “Let’s not keep it behind the walls.”

He also said that he would take the vaccine publicly when his turn eventually comes. 

Persse then came on to assuage fears over the vaccine. While it’s turned out to be a much faster process than many first thought it would be for a vaccine to be developed, there is nothing new about the infrastructure that made its development possible. 

The technology that was used to create this vaccine was the same one developed 15 years ago to fight SARS 1 (Covid-19’s official name is SARS-CoV-2), Persse noted. “From a scientific standpoint,” Persse said, “nothing has been rushed.”

He said people should not be scared of a negative physical reaction to the vaccine. Most people experience normal side effects, such as a sore shoulder, a muscle ache, a little bit of fever. People with allergies, like peanuts, latex, or shellfish, should not be worried.

While there have been reports of several people in the U.K. reacting badly, apparently they’d had poor reactions to previous immunizations. 

Since the vaccine was approved for emergency use, no one can be legally forced to take it. But both Persse and Turner strongly encourage Houstonians to get a vaccine when they can—Harris County has historically been very bad about getting immunized.

“If we want to stop wearing masks, if we want to get back to normal as a community as a state, as a nation, we have to get to herd immunity,” Persse said, his voice growing audibly emotional. “If that means I have to roll up my sleeve and have a sore arm and a low-grade fever for a couple of days, so be it.” 

To make things easier for the general public when the vaccine becomes more widely available, HHD Executive Director Dr. Stephen Williams said that people will be able to get vaccinated at their local healthcare provider. More than 500 healthcare providers in Houston have already signed up to administer vaccines when available. 

Additionally, HHD has been testing ways to mass-dispense the vaccine. Said Williams, while they haven’t decided where it would occur, the health department has planned for drive-thru vaccines, using similar models to those utilized for testing.  

Updated 9:58 p.m. Dec 11

On Friday evening the Food and Drug Administration approved the Pfizer-BioNTech Covid-19 vaccine for adults and teen age 16 and older. The decision comes after the United Kingdom approving the vaccine earlier this week, a U.S. advisory panel endorsing the vaccine yesterday, and White House Chief of Staff threatening the resignation of FDA commissioner Stephen Hahn if the vaccine was not approved by end of day Friday, according to some reports.

The FDA approved the vaccine for emergency use based on the results of a current trial of 44,000 people age 12 and older, which so far has been about 95-percent effective.

“Based on these data, and review of manufacturing information regarding product quality and consistency, it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine may be effective,” RADM Denise Hinton, the FDA’s chief scientist, wrote in an official letter of approval to Pfizer. “Additionally, it is reasonable to conclude, based on the totality of the scientific evidence available, that the known and potential benefits of Pfizer-BioNTech COVID‑19 Vaccine outweigh the known and potential risks of the vaccine, for the prevention of COVID-19 in individuals 16 years of age and older.”

The vaccine will be administered in two doses, three weeks apart from each other. Pfizer will also be required to submit monthly safety reports and quarterly manufacturing reports.

Read more here

Updated 4:11 p.m. Dec 2

Some Texans could be receiving a Covid-9 vaccine in less than two weeks. In a press release Wednesday afternoon, Gov. Greg Abbott announced that the Centers of Disease Control and Prevention has allotted 1.4 million Covid-19 vaccines to Texas for this month. The immunizations, which will be delivered beginning the week of December 14, will be distributed based on the state's vaccine distribution principles. Read more about that below. 

"The State of Texas is already prepared for the arrival of a COVID-19 vaccine, and will swiftly distribute these vaccines to Texans who voluntarily choose to be immunized," Abbott said in the release. "As we await the first shipment of these vaccines, we will work with communities to mitigate the spread of COVID-19."

Published 6:10 p.m. Nov 23

Some Houstonians could be receiving a Covid-19 vaccine before the end of the year. 

On Monday, Gov. Greg Abbott tweeted that a first round of Covid-19 immunizations could arrive in Texas by December 12. But don't get your hopes up just yet. So far, there aren't any Food and Drug Administration-approved vaccines. However, there could be before the end of the year, according to a Texas Tribune report, hence Abbott's announcement on social media. But from there, any approved vaccine will most likely be in short supply. 

Dr. David Persse, Houston's chief medical officer, said Monday that vaccines should begin arriving in  Houston over the next several weeks, although certain people like healthcare workers and those who are most vulnerable to the disease will be prioritized. "There will almost certainly be more people who want this vaccine than there will be vaccines to administer," Persse said, warning that even once the vaccines begin going out it will take time to get everyone protected against the disease.

As a result the governor has created an Expert Vaccine Allocation Panel (EVAP) to decide where and who gets the immunizations first. The 17-member panel includes state senators, researchers, doctors, and health officials from across Texas, including Houston Health Department Executive Director Stephen Williams. 

According to a release from the Department of State Health Services, the panel has created the following criteria for vaccine distribution: 

  • "Protecting health care workers who fill a critical role in caring for and preserving the lives of COVID-19 patients and maintaining the health care infrastructure for all who need it."
  • "Protecting frontline workers who are at greater risk of contracting COVID-19 due to the nature of their work providing critical services and preserving the economy."
  • "Protecting vulnerable populations who are at greater risk of severe disease and death if they contract COVID-19."
  • "Mitigating health inequities due to factors such as demographics, poverty, insurance status and geography."
  • "Data-driven allocations using the best available scientific evidence and epidemiology at the time, allowing for flexibility for local conditions."
  • "Geographic diversity through a balanced approach that considers access in urban and rural communities and in affected ZIP codes."
  • "Transparency through sharing allocations with the public and seeking public feedback."

"These guiding principles established by the Expert Vaccine Allocation Panel will ensure that the State of Texas swiftly distributes the COVID-19 vaccine to Texans who voluntarily choose to be immunized," said Abbott in a statement. "This foundation for the allocation process will help us mitigate the spread of COVID-19 in our communities, protect the most vulnerable Texans, and safeguard crucial state resources." 

According to the panel, healthcare providers will the first to get the vaccination. Because there won't be very many doses in the beginning though, healthcare workers are being divided into two tiers. Tier 1 will get the vaccines first, and if there's any left over, Tier 2 will then be vaccinated. 

First tier:

  1. "Hospital staff working directly with patients who are positive or at high risk for Covid-19. Includes: A. Physicians, nurses, respiratory therapists and other support staff (custodial staff, etc.) B. Additional clinical staff providing supporting laboratory, pharmacy, diagnostic and/or rehabilitation services."
  2. "Long-term care staff working directly with vulnerable residents. Includes: A. Direct care providers at nursing homes, assisted living facilities, and state supported living centers B. Physicians, nurses, personal care assistants, custodial, food service staff."
  3. "EMS providers who engage in 9-1-1 emergency services like pre-hospital care and transport."
  4. "Home healthcare workers, including hospice care, who directly interface with vulnerable and high-risk patients."

Second tier: 

  1. "Staff in outpatient care offices who interact with symptomatic patients. Includes: A. Physicians, nurses, and other support staff (custodial staff, etc.) B. Clinical staff providing diagnostic, laboratory, and/or rehabilitation services C. Non 9-1-1 transport for routine care."
  2. "Direct care staff in freestanding emergency medical care facilities and urgent care clinics."
  3. "Community pharmacy staff who may provide direct services to clients, including vaccination or testing for individuals who may have COVID."
  4. "Public health and emergency response staff directly involved in administration of COVID testing and vaccinations."
  5. "Last responders who provide mortuary or death services to decedents with Covid-19. Includes: A. Embalmers and funeral home workers who have direct contact with decedents B. Medical examiners and other medical certifiers who have direct contact with decedents.
  6. School nurses who provide health care to students and teachers."

The vaccine will be in two doses, but anyone who receives it won't be considered immune until about a week after their second dose. "It can either be good, or it can be alarming for us after Thanksgiving," Houston Mayor Sylvester Turner warned, as he urged Houstonians to continue to be cautious as we move closer to finally being able to ward off the disease and resume normal life.

"This vaccine is on the horizon so we just have a couple more months to get through," Mayor Pro Tem David Martin said, reminding parents that it would be wise to have any children coming home from college tested as soon as they are in town for the holidays to ensure that no one is carrying the virus home to their families.

So we're getting there, but let's not get cocky. Keep wearing your masks, y'all. 

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