When the vaccine was given at the end of last year, the message from health officials was simple: get vaccinated when you meet the conditions and get any vaccine provided to you. However, as boosters are available to certain groups of people, and low-dose injections are expected to be provided to young children soon, the movement is shifting from a set of simple instructions to more chaotic flowcharts for people who organize and provide jabs.
Take Moderna booster as an example. It was authorized by the U.S. Food and Drug Administration on Wednesday and is expected to be recommended by the Centers for Disease Control and Prevention to people 65 years of age and older and people with certain risk factors—Pfizer-BioNTech booster authorized population . But unlike Pfizer injections, the Moderna booster is a half-dose; it requires the use of the same vial as the full dose, but only half is drawn for each injection. Separately from this is the third full dose of these mRNA injections, which have been approved for immunocompromised people.
“Our workforce is exhausted and they are trying to make plans for [vaccinations] children,” said Claire Hannan, executive director of the Immunization Managers Association. “Some of our members didn’t even know that Moderna was half-dose, we just started talking about it…they all had their jaws dropped.”
From there it becomes more complicated. The FDA also authorized that the CDC is expected to recommend a second dose of Johnson & Johnson injection to all people who receive the injection as soon as Thursday—not just the narrower population considering that the booster of Moderna or Pfizer injection can be accepted. Although people vaccinated with Pfizer and Moderna are eligible for a booster six months after completing the main series of these vaccines, people vaccinated with Johnson & Johnson should get a second shot two months after the first vaccination.
In addition, the US Food and Drug Administration revealed on Wednesday that it allows a “mix and match” method with boosters, which means people don’t need to get the same injections as boosters as they do in the main series. This policy will complicate the plan, making it difficult to predict how many doses will be required in each region for booster vaccination.
Then there is Pfizer’s vaccine for 28 million children aged 5 to 11 years. FDA advisers will meet next Tuesday to discuss Pfizer’s vaccine for children aged 5 to 11 years, which means it may be available soon. The vaccine will be in a separate vial from the company’s adult injection and will use a smaller needle to deliver a 10 microgram dose, rather than the 30 microgram dose used for teenagers and adults 12 years and older.
Organizing all this will fall to pharmacies, immunization programs, pediatricians, and vaccine administrators, many of whom are exhausted, and they must also track inventory and minimize waste. This will also be a rapid transition: once the CDC has checked the last box of the booster with its recommendations, people will start demanding them.
The FDA leadership acknowledged that all of these pose challenges. “Although it is not simple, it is not completely complicated to despair,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said Wednesday during a conference call with reporters on the FDA’s new (Hyundai and Johnson) and revised releases. . Pfizer) emergency authorization.
At the same time, the public health campaign is still trying to reach tens of millions of eligible people who are completely unvaccinated.
Washington State Health Secretary Umair Shah noted that public health agencies are still keeping up with Covid-19 data, testing and response, and in some places are still dealing with the surge driven by the Delta variant. He told STAT: “Unlike those who have been responding to Covid-19, those other responsibilities or other efforts disappear.”
The most important thing is the vaccine campaign. “Then you have boosters, and then you have 5 to 11 year olds,” Shah said. “On top of what public health has been doing, you have additional stratification.”
Vendors and public health officials stated that they have experience in storing and delivering products that are different from other vaccines, and are preparing how to handle the next phase of the campaign to protect people from Covid-19. They are educating vaccine managers and establishing systems to ensure that people get the correct dose when vaccinated-whether it is a main series or a booster vaccine.
In Sterling Ransone’s family medicine practice in Deltaville, Virginia, he drew a chart outlining which groups were eligible to receive which injections and the recommended interval between different injection doses. He and his nursing staff also studied how to separate different doses of injections when taking out different doses of injections from the vials, and established a color coding system, which contains different baskets for main adult injections, and Moderna’s help. Pushers and one injection for young children are available.
“You have to stop and think about all these things,” said Lanson, president of the American Academy of Family Physicians. “What are the suggestions at the moment, what do you need to do?”
At a meeting of the FDA’s Vaccine Advisory Committee last week, one of the panel members raised concerns about “inappropriate dosage” (ie, dosage confusion) to Moderna. He asked Jacqueline Miller, the company’s head of infectious disease treatment, about the possibility of different vials for primary injections and booster injections. But Miller said that the company will still provide the same vial from which the administrator can draw a 100 microgram dose or a 50 microgram booster dose, and plans to conduct additional training.
“We recognize that this requires some education and law enforcement,” Miller said. “Therefore, we are preparing to send a’Dear Healthcare Provider’ letter explaining how to manage these doses.”
Moderna’s vaccine vials are available in two sizes, one for the main series of up to 11 doses (usually 10 or 11 doses), and the other for up to 15 doses (usually 13 to 15 doses). But the stopper on the vial can only be pierced 20 times (meaning that only 20 injections can be drawn from the vial), so the information provided to the provider by Moderna warns, “When only a booster dose or a combination of the primary series and the booster dose is extracted At this time, the maximum dose that can be extracted from any medicine bottle should not exceed 20 doses.” This restriction increases the possibility of waste, especially for larger vials.
Different doses of Moderna boosters not only increase the complexity of people pitching on a personal level. Hannan said that when the number of doses drawn from a vial begins to change, trying to monitor its supply and use of the immunization program will be an additional challenge.
“You are basically trying to track inventory in 14-dose vials, which can now be 28[-dose] vials, or somewhere in between,” she said.
For months, the United States has been flooded with vaccine supplies, and Biden administration officials touted that the country has also obtained enough vaccine supplies after obtaining authorization.
However, for children between the ages of 5 and 11, public health officials say they are not sure what kind of pediatric vaccine immunization program will initially be supplied from the federal government — and how much interest their parents will be. First. Shah said that Washington State has tried to model this demand, but there are still some unanswered questions. Survey data from the Caesars Family Foundation shows that about one-third of parents said that once the vaccine is approved, they will “immediately” vaccinate children between 5 and 11 years of age, although parents have gradually been vaccinated since they were green lighted. Warm up to vaccinate older children.
Shah said: “There are limits to the items that can be ordered in each state. We will see the demand from parents and the children they bring. This is a bit unknown.”
The Biden administration outlined plans to roll out pediatric vaccination this week before discussing the authorization next week. They include recruiting pediatricians, community and rural health centers, and pharmacies. Jeff Zients, White House Covid-19 Response Coordinator, said the federal government will provide enough supplies to states, tribes and regions to launch millions of doses. The cargo will also include the smaller needles needed to provide injections.
Helen covers a wide range of issues related to infectious diseases, including outbreaks, preparations, research, and vaccine development.