By Max Gorbaty ‘22, News Writer

As COVID-19 cases and deaths spike, the United States government rushes to complete effective and safe vaccines in collaboration with private companies. 

How are vaccines going to be produced?

Several vaccines for coronavirus-induced diseases such as Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS) have been produced in the past. After SARS-CoV-2 (COVID-19) was detected in December 2019, the genetic sequence was published in January 2020, triggering an international response to develop a vaccine. 

A traditional vaccine candidate must go through an exploratory stage, a pre-clinical stage, three-phase clinical development, US Food and Drugs Administration (FDA) review and approval, manufacturing, and quality control. Leading vaccine candidates for COVID-19 are currently in the third phase of clinical development which involves testing the vaccines on nearly 40,000 volunteers to test efficacy and safety before regulatory review.

What has been the United States response? 

Operation Warp Speed (OWS), launched in April 2020 by the Trump administration, is a public-private partnership aimed at accelerating the development, manufacturing, and distribution of 300 million doses of safe and effective COVID-19 vaccines. Operation Warp Speed aims to have the initial doses available by January 2021. 

OWS is an interagency initiative headed by the Department of Defense (DOD) and the Department of Health and Human Services. Its co-leaders are United States Army four-star general Gustave F. Perna (Chief Operating Officer) and GlaxoSmithKline’s former vaccine-department head Dr. Mancef Slaoui (Chief Scientific Advisor). Operation Warp Speed’s funding totals are nearly $18 billion. 

Several factors such as previously-developed vaccine platforms, removal of FDA red tape, and logistical support from the Department of Defense have paved the way for an expedited 14-month process. Most importantly, OWS vaccine candidates have begun executing the manufacturing process in parallel with development and trials of vaccines. That means tens of millions of doses could already be ready for distribution by the time a vaccine is approved. The accelerated development process is illustrated in Figure 1 in comparison to a typical 73-month process.

There are currently six major vaccine developers and partnerships involved in Operation Warp Speed. Some of these companies have already received upwards of $2 billion (see Figure 2) in direct payments for research and development while others have been pledged funds by OWS for manufacturing hundreds of millions of doses if the clinical trials are successful. 

What will distribution look like?

Operation Warp Speed’s General Perna has noted that the DOD is coordinating the vaccine distribution but will not play a direct role in moving or injecting vaccines. He explained, “We’re partnering with the commercial industry to do the actual distribution, because they know how to do it. They do it every year, with influenza and other medications and vaccines.” Pfizer plans to use private carriers such as UPS and FedEx to deliver vaccines. Vaccines from Moderna and other OWS candidate vaccines would likely be moved by the medical supply company McKesson, which has a contract with the government to distribute COVID-19 vaccines. Initial vaccine supplies will be allocated directly to states which may work with brick-and-mortar pharmacies such as CVS and Walgreens to vaccinate citizens or they may distribute through hospitals. 

Where are we now? How will life change with an approved vaccine?

As of November 9, there is no FDA-approved or authorized vaccine for the prevention of COVID-19. However, early data from Pfizer’s/BioNTech’s Phase III trial showed the vaccine was more than 90% effective at preventing disease in patients so far and serious health concerns have not been observed. The threshold that the FDA says that it would require for a coronavirus vaccine to be approved for emergency use is 50%. Pfizer plans to ask the FDA for emergency authorization of its vaccine later in November, after it has collected the required two months of safety data. Other promising vaccine candidates in Phase III trials are from Moderna, Johnson and Johnson, and AstraZeneca-University of Oxford. 

Although vaccine development efforts have been incredibly successful thus far, it is unlikely life will return to normal immediately following distribution. Researchers are still learning about how long natural immunity or vaccine-induced immunity last as well as what percentage of the population should achieve herd immunity. Herd immunity refers to when enough people have protection that it is unlikely coronavirus can spread more and cause disease. The world has made unprecedented strides towards developing effective COVID-19 vaccines but there are still crucial steps to be taken to achieve the safest and most desirable result. 

Figure 1: Operation Warp Speed Accelerated Vaccine Process (courtesy of the DOD) 

Figure 2: Operation Warp Speed Investments