December 14, 2020

Everything We Know So Far About The COVID-19 Vaccine Rollout In NY & NJ

GOTHAMIST 


Boxes containing the Pfizer-BioNTech COVID-19 vaccine are prepared to be shipped at the Pfizer Global Supply Kalamazoo manufacturing plant in Portage, Michigan.
Boxes containing the Pfizer-BioNTech COVID-19 vaccine are prepared to be shipped at the Pfizer Global Supply Kalamazoo manufacturing plant in Portage, Michigan on December 13th. MORRY GASH/POOL/EPA-EFE/SHUTTERSTOCK

For months now, New York and New Jersey have been held hostage by the coronavirus, subject to tighter or looser restrictions based on the infection rate, but never fully free of its grip. During that time, many have held out hope for the one thing that could potentially break the cycle: a vaccine.


Now, finally, it’s here. The U.S. Food and Drug Administration approved emergency use of the first coronavirus vaccine to make it to the finish line Friday evening after an expert advisory panel voted in favor of the move Thursday. The federal government’s Operation Warp Speed is now coordinating the shipment of an initial batch of 2.9 million doses of the vaccine, developed by Pfizer and BioNTech, across the country. The vaccine has been authorized for people age 16 and older.


A second vaccine, developed by Moderna, will be up for review by the FDA advisory panel this coming Thursday, December 17th, and the first doses will likely be distributed shortly after that, should its emergency use be granted.


But even with New York’s and New Jersey’s vaccination effort on track to get underway this month, it’s still too soon to rip off your mask and breathe a sigh of relief. Only high priority populations will be vaccinated to start, and some are still skeptical about getting vaccinated at all. A recent Siena College poll found that about two-thirds of New Yorkers are currently willing to get vaccinated, while a Rutgers-Eagleton poll found 60% of New Jersey residents welcomed a vaccine; nationally only about half of Americans are on board, according to a recent poll from The Associated Press-NORC Center for Public Affairs Research.


Around 75% of the population would need to get vaccinated in order to achieve herd immunity. If that’s accomplished by summer 2021, it’s possible that by the end of next year, “we can approach very much some degree of normality that is close to where we were before,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said this week.


For now, though, the imminent arrival of a coronavirus vaccine in New York raises a lot of basic questions about efficacy, safety and logistics

.

Here’s What We Know So Far


How will the vaccines be administered?


Both the Pfizer-BioNTech vaccine and the Moderna vaccine require two doses per person. Pfizer-BioNTech is recommending its doses be spaced 21 days apart, while Moderna is recommending 28 days.


How effective are the vaccines?


Pfizer and BioNTech say after the second dose, their vaccine proved 95% effective in preventing recipients from contracting COVID-19 in clinical trials. Moderna said its vaccine is nearly 95% effective. More research will be required to determine how long immunity provided by the vaccines lasts and whether recipients will at some point need a booster.


Can people who have been vaccinated still spread the virus?


It’s still unclear. Clinical trials for the Moderna and Pfizer-BioNTech vaccines studied whether participants were protected against contracting the virus themselves but not whether they passed it on to others. For now, the CDC recommends that people who get vaccinated continue to wear a mask.

One immunologist, Deepta Bhattacharya from the University of Arizona, told the NY Times: “Preventing severe disease is easiest, preventing mild disease is harder, and preventing all infections is the hardest.”


How do the vaccines work?


Both the Pfizer-BioNTech and Moderna vaccines use genetic material known as messenger RNA to instruct the body’s cells to produce a special protein that is unique to the coronavirus. After the proteins are created, the genetic material from the vaccine is destroyed. Recognizing the proteins shouldn’t be there, the body then produces white blood cells that remember how to fight the virus should it come back in the future.

Other vaccines in development may work differently, but none of them require injecting people with the live virus.


Do the vaccines have any negative side effects?


Some people experience initial side effects, which is common with vaccines, but that doesn’t mean they’re unsafe.


In Phase 1 trials of the Moderna vaccine, more than half of those who received it reported side effects such as fatigue, chills, headache, muscle pain, or soreness at the injection site. During Phase 3 trials of the Pfizer-BioNTech vaccine, about 3.8% of participants experienced fatigue and 2% experienced headaches.


“Just because you’re sore doesn’t mean that [the vaccine] didn’t work or wasn’t effective,” Dr. Melanie Swift, an occupational medicine physician helping to lead COVID-19 vaccination at the Mayo Clinic, told USA Today. “It just means that your body responded the way it’s supposed to.”


What about the people who had allergic reactions to the vaccine in the U.K.?


Two health care providers who received the Pfizer-BioNTech vaccine in the U.K. this week experienced anaphylactoid reactions (both carried EpiPens and recovered after using epinephrine). The U.K.’s National Health Service is now recommending that people with a history of severe allergic reactions avoid the Pfizer-BioNTech vaccine.


In the U.S., the FDA has guided healthcare providers to not administer the Pfizer vaccine at all to those with a history of severe allergic reaction to components that are in the Pfizer vaccine. This differs from a CDC official's presentation to the immunization practices panel suggesting providers should not vaccinate anyone with a history of severe allergic reactions


 to any vaccines. But the CDC's final guidance is expected Sunday, according to STATNews.

Infectious disease experts say it’s important to find out more about the effects of the vaccine, rather than ruling out its use for the millions of people who have allergies.


Fauci said this week that the reactions are most likely rare, but if they’re prevalent among a certain subset of the population, those at risk may be able to opt for one of the other vaccines in development.


How many doses will New York and New Jersey get?


Between the Pfizer-BioNTech and Moderna vaccines, New York City expects to receive more than 450,000 doses by the end of December. The number of doses shipped to each state will be based on its adult population, according to federal officials. 


Overall, the federal government has so far ordered 100 million doses of the vaccine from Pfizer-BioNTech, 200 million from Moderna and hundreds of millions more doses from companies that are still in the process of testing their vaccines.


New Jersey Governor Phil Murphy says there may be 460,000 doses by mid-January. The initial batch from Pfizer is 76,000 doses, and the first vaccines will be administered at University Hospital in Newark on Tuesday.


Who will get vaccinated first?


In New York state, the first cohort to get vaccinated will include nursing home residents, nursing home staff and health care workers in high-risk settings, Governor Andrew Cuomo said this week.


New York State’s plan indicates other essential workers—first responders, grocery store workers, transit employees—as well as those at a high-risk of severe disease from coronavirus due to other health conditions could be prioritized next. Nursing home patients and staff will be vaccinated under the CDC’s vaccination program with CVS and Walgreens.


The city Health Department says it will determine the next phases of priority groups once the CDC’s immunization practices committee decides what to recommend, but a timeline for later priority groups depends on vaccine supplies.


Like New York, New Jersey is vaccinating health care workers and long term care patients and staff first.


When will the vaccine become available to the general public?


Widespread vaccine distribution is expected by spring 2021, according to Fauci and U.S. Department of Health and Human Services Secretary Alex Azar.


How will vaccines be distributed once they arrive? 


The Pfizer-BioNTech vaccine must be stored at ultra-cold temperatures—negative 70 degrees Celsius—that not all facilities can accommodate.


New York has identified 90 regional distribution centers to receive the vaccines. In New York City, more than 50 hospitals have freezers that can store the vaccine and the Health Department can store hundreds of thousands of doses as well, for a total citywide capacity of 2 million doses.


Forty hospitals in New Jersey have ultra-cold storage.


Hospitals, as well as shipping companies like FedEx, are also placing large orders for dry ice in order to ensure the vaccine’s successful transport.


Where will people get vaccinated?


When the vaccine is rolled out more broadly, it will likely be available in all the places that typically offer vaccinations. Doctors’ offices, pharmacies, and other health care providers are now able to enroll in the NYC COVID-19 Vaccination Program, according to a memo sent out by the NYC Health Department this week. Only select entities, such as hospitals, nursing homes, and home health agencies, will be able to get the vaccine in the first phase of distribution, however.


The city is prepared to set up emergency vaccination sites at locations besides vaccination programs at hospitals or nursing homes. 


How much will the vaccine cost?


The vaccine is supposed to be free for everyone, regardless of what kind of insurance they have or if they are uninsured.


The federal Centers for Medicare and Medicaid Services has laid out a plan to make sure this happens, including a program that will reimburse health care providers for administering the vaccine to people who are uninsured. The CMS also aims to create special billing codes for the vaccine that will be easily recognized by insurers. Still, health care billing is an imprecise science, so it will be important for vaccine recipients to keep an eye out for any unanticipated charges.


Additional reporting by Jen Chung and Sydney Pereira.