U.S. health secretary says 6 million doses ready to ship as soon as the FDA approves vaccine’s use

A panel of outside advisers to the U.S. Food and Drug Administration is expected to endorse emergency use of Moderna Inc.’s coronavirus vaccine during a meeting on Thursday, as the nation prepares to roll out a second vaccine.

The panel vote on whether the vaccine’s benefits outweigh its risks is likely to come in the late afternoon, with an FDA authorization expected as soon as Friday.

It is the same committee of expert advisers that last week backed the COVID-19 vaccine from Pfizer Inc. and German partner BioNTech SE, clearing the way for the FDA emergency use authorization (EUA) a day later.  A massive inoculation program began at U.S. hospitals on Monday.

The Moderna vaccine uses similar messenger RNA technology but with less onerous cold storage requirements than the Pfizer/BioNTech shot, making it a better option for remote and rural areas. Both vaccines were about 95 percent effective in preventing illness in pivotal clinical trials.

SVB Leerink analysts said the Moderna vaccine appears less tolerable than the Pfizer/BioNTech shot, but noted that is not a proper comparison across trials and unlikely to stand in the way of a EUA.

The FDA staff did not raise any serious concerns about safety in documents published on Tuesday in preparation for the meeting. It said a link between Bell’s palsy, which causes temporary paralysis of facial muscles, and the vaccine could not be ruled out after some cases were reported in trials of both vaccines.

Moderna is seeking authorization for people aged 18 and older.

Some cases of allergic reactions to the Pfizer-BioNtech shot have been reported in the United States and Britain since the rollout began.

No cases suggestive of anaphylaxis to Moderna’s vaccine were identified after analyzing safety data from clinical trials, Moderna executive David Martin said at Thursday’s meeting.

Two cases of the severe, potentially life-threatening allergic reaction occurred in Moderna’s large clinical study, one among those who received the vaccine and the other in the placebo group, Martin said.

The vaccine recipient with the allergic reaction had a history of asthma and a shellfish allergy, he said.

U.S. government eager to deploy the vaccine

The Massachusetts-based company, which has never produced a vaccine on this scale, is working with multiple partners to produce its vaccine, including Switzerland’s Lonza.

Initial Moderna vaccine supply would likely go to the United States, which has signed deals to secure as many as 200 million doses and is expecting the first 20 million this month. The vaccine is administered in two doses about four weeks apart, a longer interval than Pfizer’s three-week period before the second shot.

Meanwhile, the FDA said it is working with Pfizer to revise fact sheets and prescribing information on the Pfizer-BioNTech shot after two health care workers in Alaska experienced allergic reactions minutes after receiving the vaccine, FDA official Doran Fink said at Thursday’s panel meeting.

“We anticipate that there may be additional reports, which we will rapidly investigate,” Fink said.

The White House is eager to deploy the Moderna vaccine, given the toll the virus has exacted on the U.S. There were 3,400 deaths attributable to the coronavirus across the country, the COVID Tracking Project from The Atlantic magazine reported on Wednesday. The death toll since the start of the pandemic in the U.S. recently passed 300,000 Americans.

The U.S. Health and Human Services Secretary Alex Azar on Thursday said nearly 6 million doses of Moderna Inc.’s experimental COVID-19 vaccine were poised to ship nationwide as soon as it secures Food and Drug Administration approval.

“We’re ready to start shipping this weekend to them for rollout Monday, Tuesday, Wednesday of next week. We’re ready to go,” Azar said.

The company has also signed supply deals with Canada, the European Union, and the U.K. The vaccine is undergoing a “rolling review” by regulators for all three.

Prime Minister Justin Trudeau said this week it is expected Canada will receive 168,000 doses of Moderna’s vaccine before the end of the year, contingent on an expected approval soon from Health Canada.

In total, six million Moderna and Pfizer vaccines are expected to be delivered to Canada by the end of March 2021, the government has said.

Unlike the Pfizer vaccine, which is being delivered directly by the company to points of use, the federal government will be responsible for the logistics associated with importing the Moderna shot and distributing the product to the provinces and territories.

Health experts are on the verge of possibly having two COVID-19 vaccines and ABC13 has learned how the two compare.

According to the FDA, it was 94.1% effective in preventing symptomatic cases. The Pfizer vaccine has claimed a 95% effectiveness.

Both vaccines require two doses, however. For those receiving the Pfizer vaccine, the second dose is administered 21 days after the first. Moderna’s second dose is administered 28 days after the first.

They both also developed the messenger RNA, a new type of vaccine that creates a blueprint for those essential antibodies, without actually infecting people with COVID-19.

They differ once again in how they are stored.

Pfizer’s needs to be stored at 94 degrees below zero. After it thaws, it can be stored in a normal fridge for five days.

Moderna’s vaccine still needs to be kept cold, but rather at a standard freezer temperature, negative four degrees. After it thaws, it can be refrigerated for 30 days.

Pfizer’s vaccine was authorized for people ages 16 and up. Moderna is still seeking authorization for people 18 and older.

The side effects seem to be the biggest thing on people’s minds. So far minor temporary side effects like tiredness and headache have been reported by the CDC.

Here’s a full list of possible side effects that both vaccines can have on people:

• Pain at the site of injection

• Headache

• Fever

• Fatigue

• Chills

• Muscle and joint pain

The difference is that the Moderna vaccine’s side effects were found to be more common after the second dose. Either way, health experts said people may want to consider taking the day off work after getting the second shot.

There are still some areas we need to learn more about. For example, how the vaccine works in children and in pregnant women. Many are also wondering if you can choose which vaccine to get.

Dr. Jill Weatherhead said it’s very unlikely people will get to choose which vaccine they get because it’ll depend on which is available in their area.

Vaccines must not be mixed and matched.

On Tuesday, the first Houston nurses and doctors received a card showing which vaccine they took. Others are likely to get something similar, so it can be presented when receiving the second dose.

U.S. officials said Wednesday they quarantined several thousand doses of Pfizer’s coronavirus vaccine in California and Alabama this week after an “anomaly” in the transportation process caused the storage temperature to get too cold.

Pfizer’s vaccine, which was developed with German drugmaker BioNTech, requires a storage temperature of around minus 70 degrees Celsius. Vials of the vaccine are stored in trays, which carry a minimum of 975 doses each, according to the Centers for Disease Control and Prevention.

The vaccine “never left the truck,” he said during a press briefing Wednesday. “We returned them immediately back to Pfizer and we sent immediate shipments to replace those two trays. We’re working with the FDA now, CDC, FDA, and Pfizer to determine if that anomaly is safe or not, but we’re taking no chances and we can see that.”

He said the “anomaly” happened again in Alabama.

“All the way on the other side of the country in Alabama, two trays were received at one location. The same anomaly went to minus 92. We were able to stop and quarantine the vaccine, stop and get a replacement shipment to Alabama,” he said.

It’s unclear what caused the storage temperature to fall. Pfizer didn’t immediately return a request for comment.

Americans began receiving some of the first shots of Pfizer’s vaccine on Monday after the Food and Drug Administration authorized Pfizer’s vaccine Friday. Officials and medical experts had already acknowledged that Pfizer’s vaccine would present some new logistical challenge as it has to be stored at ultracold temperatures.

“We’re talking super cold. It’s completely unprecedented,” Soumi Saha, a pharmacist and vice president of advocacy for Premier, a consulting firm that works with thousands of hospitals and nursing homes.

She said it was “completely new territory” for health systems. “And so this is a brand new logistical challenge in order to distribute this vaccine and get it to the right place and to do so while maintaining the integrity of the product,” she said.

During the briefing, Perna said vaccine deliveries in the U.S. remain on track, with another 886 deliveries expected to be shipped across the nation Thursday. The federal government delivered 2.9 million doses of Pfizer’s vaccine this week. Next week, the government plans to ship an additional 2 million doses of Pfizer’s vaccine as well as 5.9 million doses of Moderna’s vaccine if cleared by the FDA, Perna said.

The FDA’s Vaccines and Related Biological Products Advisory Committee, an outside group of medical experts that advises the agency, votes on whether to recommend Moderna’s vaccine for emergency use on Thursday. A favorable vote from the committee will likely clear the path for Moderna’s vaccine to become the second one approved for use in the U.S. behind Pfizer’s. FDA clearance could come as early as Friday.

“It’s about a steady cadence of deliveries to the American people,” Perna said.

Moderna’s COVID-19 vaccine is the next to be considered for emergency use authorization in the United States after the vaccine by Pfizer and BioNTech was approved last week.

Shipments of a second vaccine are likely to coming soon as the FDA gives authorization for the Moderna vaccine.

“The FDA found no serious safety concerns with the Moderna vaccine and affirmed its 95% efficacy,” Gov. JB Pritzker said.

Moderna and Pfizer vaccines are similar in terms of dosage. Both vaccines require two doses with three weeks in between for Pfizer and four weeks for Moderna. However, they differ in storage. Moderna does not require extremely low temperatures. It is likely that the Pfizer vaccine stays at hospitals when it comes to distribution.

“Using that to vaccinate healthcare workers makes more sense than taking that to the long-term care facilities, so it might be that Moderna is used more for that upfront than the Pfizer vaccine,” said Dr. Stephen Schrantz, University of Chicago Medicine.

Moderna has yet to reveal details about its vaccine and distribution plan. Unlike Pfizer, Moderna is a small company that will work with outside contractors.

“The whole distribution plan with Moderna is very different from Pfizer because essentially there is a company called McKesson that is going to handle the entire distribution of the vaccine,” said Hani Mahmassani, director of Northwestern University Transportation.

When Moderna arrives at its destination points, handling the vaccine will be easier than Pfizer due to the less extreme temperature requirements, according to Professor Mahmassani. The Moderna vaccine will be coming from the East Coast instead of Michigan and Wisconsin, where the Pfizer vaccine is located, Mahmassani added.
“From day one, when people ask me, ‘What can go wrong?’ I said, ‘Weather,'” Mahmassani said.

The vaccine will likely not be from Moderna or Pfizer by the time most people get the vaccine. Experts said there will likely be another vaccine in the pipeline that requires one dose and regular refrigeration.