Kristen Coppock, MA, Managing Editor

Moderna’s vaccine candidate for the coronavirus disease 2019 (COVID-19) has been 

recommended for Emergency Use Authorization

 (EUA) by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), according to the company.

 This new COVID-19 vaccine (mRNA-1273) candidate was deemed highly effective in a filing released by the VRBPAC on Tuesday.



“We have been working with the [CDC] and Operation Warp Speed to prepare for the distribution of mRNA-1273, if the FDA chooses to grant an [EUA]. We look forward to getting our vaccine to people in the US to help address this ongoing public health emergency,”  said Stéphane Bancel, CEO of Moderna, in a prepared statement released Thursday.



On Thursday, 20 VRBPAC members voted in favor of the recommendation with no members voting against it, and 1 member abstained, according to Moderna. Although the VRBPAC’s recommendation is nonbinding, the FDA will take it into consideration in making a final decision on granting an EUA.

The FDA previously approved an EUA application for the first COVID-19 vaccine to be distributed in the United States. The BNT162b2 vaccine was jointly developed by Pfizer and BioNTech.

In addition to announcing the VRBPAC's recommendation, Moderna announced Friday a purchase of additional 80 million doses of mRNA-1273 by the European Commission (EC). The additional doses bring the EC’s confirmed order commitment to 160 million doses, which will commence from the company’s dedicated European supply chain, according to Moderna.

Moderna Receives FDA Advisory Committee Vote Supporting Emergency Use for Moderna’s Vaccine Against COVID-19 in the United States [news release]. Cambridge, MA; December 17, 2020: Moderna. Accessed December 17, 2020. 

https://investors.modernatx.com/news-releases/news-release-details/moderna-receives-fda-advisory-committee-vote-supporting

FDA Briefing Document: Moderna COVID-19 Vaccine. FDA Vaccines and Related Biological Products Advisory Committee. Published December 15, 2020. Accessed December 17, 2020. 

https://www.fda.gov/media/144434/download

Moderna COVID-19 Vaccine Shows High Efficacy, Clearing Path for EUA. 

®. Published December 15, 2020. Accessed December 17, 2020. 

https://www.pharmacytimes.com/news/moderna-covid-19-vaccine-shows-high-efficacy-clearing-path-for-eua

FDA Grants Historic Emergency Use Authorization to COVID-19 Vaccine From Pfizer and BioNTech. 

. Published December 12, 2020. Accessed December 18, 2020. https://www.pharmacytimes.com/news/fda-grants-historic-emergency-use-authorization-to-covid-19-vaccine-from-pfizer-and-biontech

European Commission exercises option for additional 80 million doses of Moderna’s COVID-19 vaccine candidate [news release]. Cambridge, MA; December 18, 2020: Moderna. Accessed December 18, 2020. 

https://investors.modernatx.com/news-releases/news-release-details/european-commission-exercises-option-additional-80-million-doses

Articles

This new COVID-19 vaccine (mRNA-1273) candidate was deemed highly effective by an FDA advisory committee. 

Moderna’s COVID-19 Vaccine Receives FDA Committee Recommendation for Emergency Use

The investigational drug remdesivir demonstrated that a 10-day treatment course achieved similar improvement in the clinical status of patients as a 5-day treatment course. Announced today by Gilead Sciences, these topline results were culled from an open-label phase 3 SIMPLE trial evaluating 5-day and 10-day dosing durations of the antiviral in hospitalized patients with severe manifestations of the coronavirus disease 2019 (COVID-19).

No new safety signals were identified with remdesivir across either treatment group, according to Gilead.

Remdesivir is not approved by the FDA nor licensed or approved anywhere in the world. The drug has not yet been demonstrated to be safe or effective for the treatment of COVID-19.

However, remdesivir, a nucleotide analog with broad-spectrum antiviral activity, has demonstrated activity against MERS and SARS, indicating that it may have potential activity against COVID-19.

Due to the COVID-19 pandemic, the FDA designated

allowing patients with serious or life-threatening cases of the virus to have access to the drug.

Remdesivir has also been granted the investigational antiviral Orphan Drug status by the FDA.

“Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping to inform whether remdesivir is a safe and effective treatment for COVID-19, and how to best utilize the drug,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences, in a prepared statement.

A version of this article was originally published by Pharmacy Times. Read the full article at

Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients with Severe COVID-19 [news release]. Foster City, CA; April 29, 2020: Gilead Sciences. [email]. Accessed April 29, 2020.

Coppock K. FDA Announces Two Drugs Given ‘Compassionate Use’ Status in Treating COVID-19.

https://www.pharmacytimes.com/news/fda-announces-two-drugs-approved-for-compassionate-use-in-treating-covid-19

Published March 19, 2020. Accessed April 29, 2020.

Hippensteele A. Potential COVID-19 Treatment Granted Orphan Drug Status.

https://www.pharmacytimes.com/news/potential-covid-19-treatment-granted-orphan-drug-status

Published March 25, 2020. Accessed April 29, 2020.

Remdesivir is not approved by the FDA nor licensed or approved anywhere in the world.

Remdesivir Trial Demonstrates Positive Results for Patients with COVID-19

The American Medical Association, American Pharmacists Association, and American Society of Health-System Pharmacists issued a joint statement Wednesday addressing inappropriate ordering, prescribing, or dispensing of medications for treating the novel coronavirus (COVID-19). The statement also highlights the important roles that pharmacists, physicians, and health systems play in being just stewards of health care resources during times of emergency, and national disaster.

“Physicians’ and pharmacists’ first and foremost ethical obligation in situations of epidemic, disaster, or terrorism is to provide urgent medical care, and ensure availability and appropriate use of necessary medications. This requires close coordination with the entire health care team to help ensure patients receive the testing, treatments, follow-up care, and medications they need,” the statement reads.

According to the statement, these professional organizations are aware that some physicians and others are prophylactically prescribing medications currently identified as potential treatments for COVID-19, typically for themselves, their families, or their colleagues. These medications include chloroquine or hydroxychloroquine, and azithromycin. In addition, some pharmacies and hospitals have been purchasing excessive amounts of these medications in anticipation of potentially using them for COVID-19 prevention and treatment.

“We strongly oppose these actions. We collectively support state and federal requirements that direct a prescription must be written only for a legitimate medical purpose,” the statement reads. “We also strongly support a pharmacist’s professional responsibility to make reasonable inquiries to a prescriber to resolve any questions about a prescription. If a prescription is not for a legitimate medical purpose, it should not be written, and it should not be dispensed."

use in treating COVID-19. Neither of these 2 drugs are approved by the FDA for treating this virus, although chloroquine is approved for other indications, including malaria. The compassionate use authorization allows patients with serious or life-threatening cases of COVID-19 to have access to them as investigational medicinal products, as prescribed therapies.

The organizations’ joint statement emphasized that whether these medications are used to treat COVID-19 is a determination that should be made on a case-by-case basis with physicians, pharmacists, and other members of the health care team working together and resolving questions.

“We applaud the innumerable selfless acts by health care professionals across the nation who are putting themselves in harm’s way to provide care to America’s patients," the organizations said.

However, the statement also cautioned hospitals, health systems, and individual practitioners that, along with lack of FDA approval for treating patients with COVID-19, there is no incontrovertible evidence to support off-label use of medications for this virus. The organizations urged against stockpiling of these medications for COVID-19 with a warning that doing so could have grave consequences for patients with conditions for which these medications are indicated by FDA approval.

“The health care community must collectively balance the needs of patients taking medications on a regular basis for an existing condition with new prescriptions that may be needed for patients diagnosed with COVID-19. Being just stewards of limited resources is essential,” the statement reads.

In addition, the organizations addressed confusion possibly resulting from state government agencies and boards that are issuing emergency rules limiting or restricting access to chloroquine, hydroxychloroquine, or other emerging therapies, or requiring new procedures for physicians, other health care professionals, and patients. They urged state government agencies and boards to emphasize professional responsibility, and a need for professional judgement under these new policies.

“In a time of national pandemic, now is not the time for states to issue conflicting guidance, however well-intentioned, that could lead to unintended consequences,” the associations said. “The nation’s physicians and pharmacists continue to demonstrate remarkable leadership on a daily basis. We are confident in physicians’ and pharmacists’ judgment to make the right decisions for their patients, communities and the health care system overall.”

Finally, the statement applauds continuing efforts to conduct clinical trials and generate evidence related to medications that could help mitigate the pandemic. That some pharmaceutical manufacturers are increasing production of high-demand medications, as well as supplying them for use in clinical trials, is encouraging, according to the associations.

Joint Statement of the American Medical Association, American Pharmacists Association, and American Society of Health-System Pharmacists on Inappropriate Ordering, Prescribing or Dispensing of Medications to Treat COVID-19 [news release]. AMA, APhA, ASHP. [email] Issued March 25, 2020. Accessed March 25, 2020.

FDA Announces Two Drugs Given ‘Compassionate Use’ Status in Treating COVID-19.

Published March 19, 2020. Accessed March 25, 2020.

According to the statement, these professional organizations are aware that some physicians and others are prophylactically prescribing medications currently identified as potential treatments for COVID-19.

Health Care Organizations Issue Statement on Medications for the Coronavirus

President Donald J. Trump today invoked the Defense Production Act in an effort to increase medical supplies to combat the novel coronavirus (COVID-19) pandemic. In a White House press conference Wednesday, federal health officials also said there is increasing capacity for testing to detect the virus.

The Defense Production Act allows for the expedition and expansion of supply resources from US industries to support federal programs.

In this case, manufacturers are being tasked with increasing production of ventilators, face masks, and other medical supplies needed by the health care industry for the treatment and prevention of COVID-19.

Vice President Mike Pence has also called for the use of industrial ventilation masks, such as those used by construction workers, to be diverted to hospitals for use by health care professionals.

In addition, a pair of Department of Defense hospital ships, Mercy and Comfort, are being prepared for potential service to the United States and could be called into action to help serve patients, Trump said. Although these ships are not yet needed, Trump said, “They can be launched over the next week or so.”

According to members of the White House’s Coronavirus Task Force, the federal government is making strides with testing for COVID-19. “We’re increasing the number of tests being performed by the thousands each day,” Pence said.

Deborah Birx, MD, pointed to recent emergency use authorizations (EUAs) granted by the FDA with increasing testing capacity across the United States. She credited private companies Therma Fisher Scientific and Roche Molecular Systems,

each of which has an EUA for COVID-19 testing

, with helping to clear a backlog of tests.

“We asked them to prioritize the regions that were most affected [by COVID-19],” Birx said.

“We will see the number of people diagnosed increase over the next 4 to 5 days [as the backlog clears].”

for COVID-19 tests. These EUAs were granted to Hologic and Laboratory Corporation of America.

Trump also announced a potential self-swab COVID-19 test option that is not yet approved by the FDA. This method, he said, would help testing be conducted more quickly for each patient and would allow health care workers additional time for more patients or other tasks.

“It would be administered by health officials, but it would be a lot easier to do,” Trump said.

“We have a current process that’s a bit difficult.”

During the press conference, CMS Administrator Seema Verma recommended that elective procedures be curtailed during the pandemic as another way to conserve resources. She said that doing so would help preserve medical equipment and would allow health care workers more time with patients who have immediate needs. Curtailing elective procedures also would help more patients avoid contracting COVID-19, she said.

A version of this article was originally published by Pharmacy Times. Visit

for more up-to-date news for on the coronavirus pandemic.

Coronavirus Task Force. White House press conference. Washington, DC; March 18, 2020.

FEMA. Defense Production Act Authorities. FEMA website.

https://www.fema.gov/defense-production-act-overview

Updated August 13, 2018. Accessed March 18, 2020.

White House Coronavirus Task Force Press Briefing. Presented online: March 16, 2020; Washington, DC.

Antrim A. FDA Issues COVID-19 Diagnostic Emergency Use Authorization to Hologic, LabCorp.

https://www.pharmacytimes.com/news/fda-issues-covid-19-diagnostic-emergency-use-authorization-to-hologic-labcorp

Published March 17, 2020. Accessed March 18, 2020.

Federal health officials also said there is increasing capacity for testing to detect the virus.

Articles

Moderna’s COVID-19 Vaccine Receives FDA Committee Recommendation for Emergency Use

Remdesivir Trial Demonstrates Positive Results for Patients with COVID-19

Health Care Organizations Issue Statement on Medications for the Coronavirus

Access to COVID-19 Medical Supplies Expected to Increase Under Defense Production Act