What to Know About Timing and Distribution of Coronavirus Vaccines | National News

Back-and-forth announcements from two major companies – Pfizer and Moderna – about the high efficacy of their coronavirus vaccines has peaked hope in a possible light at the end of the tunnel as the U.S. experiences more infections than ever before, but questions remain about timing, distribution and storage.

The companies announced this week that their vaccines are both over 94% effective in preventing the virus, and both are expected to soon file for emergency use authorization with the Food and Drug Administration.

“If these two vaccines do get approval, emergency use authorization, there will be about 40 million doses ready to be delivered in December,” Francis Collins, the director of the National Institutes of Health, told CNN this week.

Considering each person requires two doses, “that’s 20 million people that can be immunized, and we will need to make sure that is utilized for the highest risk people,” he said.

“The hope would be that by April we really start to see a lot of people getting immunized and certainly by the summer we would hope to have most of America actually immune to this and we could start to think about getting back to life as normal,” Collins said.

But the U.S. Government Accountability Office on Tuesday warned in a report that limited production capacity could slow vaccine distribution.

“Before the pandemic began, most manufacturing resources were being used for other vaccines, and private industry representatives working on COVID-19 vaccines have told us they’ve had trouble obtaining these resources,” the GAO said in its blog.

Before distribution even begins, the vaccines would need to be approved by the Food and Drug Administration for emergency use, which could happen next month under an accelerated timeline.

The FDA is planning a meeting for its vaccine advisory committee in December to consider the vaccines for approval, CNN reports.

According to CNN, sources said that the FDA “could make a decision at the end of the meeting on Dec. 10 about whether to issue emergency use authorizations for the vaccines.”

Following any potential approval, the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet within 24-48 hours to review the data and recommend which group receives it first. It will also decide if some people should be excluded from getting the vaccine.

Some health experts have said that health care workers should be the first to get a vaccine. Dozens of traditional pharmacies and pharmacies in retail and grocery stores have signed on to administer coronavirus vaccines once one is approved and available to the public.

The percentage of people willing to get a coronavirus vaccine has increased over the past couple months, according to a recent poll from Gallup.

While the poll was completed before the most recent announcements from Pfizer and Moderna, it found that 58% of Americans would get a vaccine – up from 50% in September.

But the U.S. is expected to see hundreds of thousands more deaths from the virus before the vaccine is widely available in the spring. Health officials have urged citizens to continue following mitigation measures like wearing a mask and social distancing.

Here is where leading vaccine candidates stand.

The chief executive officer of BioNTech, which is working with Pfizer on the vaccine, told CNN that the companies will file for an emergency use authorization from the FDA on Friday.

Pfizer announced on Wednesday that the vaccine is 95% effective in preventing the virus and has no serious side effects.

The vaccine, which needs to be stored in extreme cold at nearly 100 degrees below zero Fahrenheit, will be put in custom-made boxes designed by the company’s engineers, according to Pfizer CEO Albert Bourla.

Each box can hold about 1,000-5,000 vaccine doses, Bourla said in an interview hosted by The New York Times. The boxes will eliminate the need for additional freezing during delivery, and the company expects to be able to ship them out to most places across the U.S. overnight.

“Once we receive an address from the government, the next day, the product will be there,” he said. “Once people receive it, they can keep it for weeks in the box, or they can keep it for months in freezers.”

The CEO said he is less concerned about storage and more concerned about meeting demand for the vaccine.

“The biggest challenge will be that in the beginning, the dose availability will be smaller than the demand,” Bourla said.

The U.S. has agreed to spend nearly $2 billion for 100 million doses of the companies’ potential vaccine with the chance to acquire up to 500 million additional doses.

Government officials have said the vaccine would be delivered at no cost to Americans, but Pfizer over the summer did not commit to Congress to sell the vaccine at cost.

The company this week reported that its vaccine is 94.5% effective and that it intends to apply for emergency use authorization in the “coming weeks.”

“This is a pivotal moment in the development of our COVID-19 vaccine candidate,” Moderna CEO Stéphane Bancel said in a statement. “Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease.”

The vaccines from both Moderna and Pfizer rely on messenger RNA, or mRNA, to provoke an immune response. The process uses genetic material copied from the virus to mimic its infection and generate an immune response. The vaccines would be the first to use mRNA in humans, if successful.

While the Moderna and Pfizer vaccines have several similarities, including that both require two doses, they have one important difference: Moderna’s vaccine can be stored in a standard home or medical refrigerator for up to 30 days.

Officials expect the vaccines to be used fairly quickly upon delivery, but the storage flexibility is an advantage.

Moderna said in August that it plans to price the vaccine under $40 per dose in most cases. It hopes to have 20 million doses ready to ship in the U.S. by the end of the year.

Unlike the vaccines from Moderna and Pfizer, Johnson & Johnson’s vaccine candidate would only require one dose.

A vaccine that requires just one dose would be logistically easier to produce and roll out than one that requires two doses with time in between each dose.

Like Johnson & Johnson, the vaccine trial from AstraZeneca and the University of Oxford was also paused after a participant fell ill. It similarly resumed last month.

Data from the trial should be available before the end of the year.

The vaccine works through non-replicating viral vectors, which means the vaccine doesn’t contain the actual coronavirus but rather a dead or weakened virus that has genetic material from the coronavirus.