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Explainer: How the COVID vaccines were developed so quickly

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December 4, 2020

The development of a new vaccine usually takes a decade. The discovery and research phase alone normally takes two to five years. The fastest vaccine ever created—for the mumps—took four years. The time it took to develop a vaccine for COVID-19 was less than a month. We may soon have a vaccine ready for widespread use that was developed, tested, approved, and distributed in less than a year.  

The two most promising vaccines—independently produced by Pfizer and Moderna—were developed so quickly because they use mRNA, which does not require time-consuming steps, such as growing ingredients in chicken eggs (see more on this below). But the creation involved the collaboration of a global network of biomedical researchers, pharmaceutical companies, and government agencies. 

To show how the incredible process was achieved so quickly, we’ll examine the timeline for the creation of the vaccine by Moderna

Development

A new viral-caused respiratory illness was first discovered in the Hubei province of China in December 2019. A few weeks later, cells from infected patients were used to isolate this new severe acute respiratory syndrome coronavirus, which was named the SARS-CoV-2. By Jan. 11, medical researchers in China had sequenced the genome for the coronavirus and posted the details on GenBank, the National Institute of Health’s (NIH) genetic sequence database which contains an annotated collection of all publicly available DNA sequences.

Two days after the genome was posted, the NIH and Moderna’s infectious disease research team finalized the sequence for a candidate vaccine, mRNA-1273. The biotechnology company then immediately began to manufacture the candidate vaccine for clinical testing. On Feb. 7, a mere 25 days later, the first clinical batch of mRNA-1273 was completed and then proceeded to analytical testing for release. 

Testing

Three weeks later, Moderna shipped the first clinical batch of mRNA-1273 to the NIH for use in their Phase 1 clinical study. By March 16, the NIH announced that the first participant in its Phase 1 study of mRNA-1273 was dosed—a total of 63 days from sequence selection to first human dosing.

Before vaccines and antivirals can be approved for use on humans, the Federal Drug Administration (FDA) requires they undergo rigorous study, such as through a clinical trial. Clinical trials are research studies that evaluate the effectiveness of a medical, surgical, or behavioral intervention and are the primary way researchers find out if a new treatment, such as a vaccine, is safe and effective for use on people. 

Clinical trials advance through four phases to test a treatment, find the appropriate dosage, and look for side effects:

Phase I — The drug is given to a small number of healthy people and people with a disease to look for side effects and figure out the best dose. The NIH announced that the first participant in its Phase 1 study of mRNA-1273 was dosed on March 16 and Moderna announced positive interim Phase 1 data for mRNA-1273 on July 8.

Phase II — The drug is then given to several hundred people who have the disease, looking to see whether it works and if there are any side effects that weren’t caught during the initial testing. Moderna began phase 2 on May 29 and completed enrollment on July 8.

Phase III — In this large-scale trial, the drug is given to several hundred or even up to 3,000 people. A similar group of people take a placebo, or inactive compound. The trial is usually randomized and can take one to four years. This stage provides the best evidence of how the drug works and the most common side effects. Moderna began phase on July 27 and completed enrollment on Oct. 22.

Phase IV — Drugs that are approved for use undergo continued monitoring to make sure there are no other side effects, especially serious or long-term ones. Moderna has requested emergency FDA authorization for its vaccine candidate. To win FDA authorization, companies have to show their vaccine is safe, that it’s more than 50% effective, and that it can be produced reliably and safely. A preliminary analysis shows that mRNA-1273 has a vaccine efficacy of 94.5%.

By the middle of December, the FDA is expected to decide whether to authorize the Moderna and Pfizer vaccine candidates. 

Funding and distribution

On April 16, the Health and Human Services Department (HHS) agreed to provide up to $483 million in support available for Moderna’s candidate vaccine. The funding allowed Moderna to increase its “skilled manufacturing staff to expand manufacturing capacity from two shifts per day, 5 days per week to three shifts per day, 7 days per week, engineers to manage process scale-up, and clinical and regulatory staff to support clinical development.” (This agreement was later expanded on July 26 to include an additional $472 million to support late-stage clinical development, including the expanded Phase 3 study of the company’s mRNA vaccine, which began on July 27.)

The funding for the Moderna vaccine began before May 15, when the U.S. government announced the launching of Operation Warp Speed, a program designed to drastically reduce the time it takes to get a COVID-19 vaccine to U.S. residents. The goal of Operation Warp Speed is to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021. The project was funded by almost $10 billion that Congress had directed to this for fighting the disease. 

In August, HHS announced that up to $1.5 billion in funds would be authorized to support the large-scale manufacturing and delivery of Moderna’s vaccine candidate. Under the terms of the agreement, the U.S. government will own the resulting 100 million doses of vaccine and will have the option to acquire more. Moderna has partnered with the Swiss drugmaker Lonza to produce 400 million doses of the vaccine annually. The U.S. firm is aiming for 500 million to 1 billion doses in total for 2021. 

Is a vaccine safe being developed on such a short timeline?

The speed with which the vaccines have been developed has raised concerns about whether they are safe. Many people may assume that because previous vaccines took years to create, that a deliberate process over an extended time is an essential element in ensuring safety. But the reality is that the COVID vaccines were able to be developed so quickly because they took advantage of relatively recent technological advances and prioritization that speeded up the regulatory process. 

For example, a key first step in creating modern vaccines is determining the genetic sequence of the virus. The first complete genome sequence from a free-living organism (Haemophilus Influenzae) only occurred in 1995. When the coronavirus-induced SARS outbreak began in late 2002, it took scientists six months—until April 2003—to sequence the genome of the virus. In comparison, it took researchers a mere 33 days to sequence the genome of the COVID-19 virus.

Another hurdle in the process is the manufacture of the vaccine. For instance, the most common way flu vaccines are made is using an egg-based manufacturing process. In this process, a candidate vaccine is injected into fertilized chicken eggs and incubated for several days to allow the viruses to replicate. One egg is needed to produce one dose of a vaccine. This requires large numbers of chicken eggs to produce (about 140 million eggs are needed in the U.S. every flu season) which can take a long time. Even for a simple flu vaccine it often takes 5–7 months for the World Health Organization (WHO) to send out the viruses it has chosen and the vaccine industry to receive the shipment, replicate the viruses, and manufacture millions of vaccines. The production method for mRNA vaccines is much simpler, and takes much less time. 

According to the Centers for Disease Control, mRNA vaccines have been rigorously tested for safety before being authorized for use in the United States. And while the  COVID-19 mRNA vaccines have received priority attention by federal regulators, they still go through the same rigorous safety assessment as all vaccines before they are authorized or approved for use by the Food and Drug Administration.

The COVID-19 Vaccines: A Conversation with Dr. Francis Collins

On Thursday, ERLC hosted a discussion about the COVID-19 vaccines with Dr. Francis Collins, the Director of the National Institutes of Health. During our event he shared insights about the development of the vaccines, misconceptions about them, and what it will take to get our church life back to “normal.” Watch the full video

Article 12: The Future of AI

We affirm that AI will continue to be developed in ways that we cannot currently imagine or understand, including AI that will far surpass many human abilities. God alone has the power to create life, and no future advancements in AI will usurp Him as the Creator of life. The church has a unique role in proclaiming human dignity for all and calling for the humane use of AI in all aspects of society.

We deny that AI will make us more or less human, or that AI will ever obtain a coequal level of worth, dignity, or value to image-bearers. Future advancements in AI will not ultimately fulfill our longings for a perfect world. While we are not able to comprehend or know the future, we do not fear what is to come because we know that God is omniscient and that nothing we create will be able to thwart His redemptive plan for creation or to supplant humanity as His image-bearers.

Genesis 1; Isaiah 42:8; Romans 1:20-21; 5:2; Ephesians 1:4-6; 2 Timothy 1:7-9; Revelation 5:9-10

Article 11: Public Policy

We affirm that the fundamental purposes of government are to protect human beings from harm, punish those who do evil, uphold civil liberties, and to commend those who do good. The public has a role in shaping and crafting policies concerning the use of AI in society, and these decisions should not be left to those who develop these technologies or to governments to set norms.

We deny that AI should be used by governments, corporations, or any entity to infringe upon God-given human rights. AI, even in a highly advanced state, should never be delegated the governing authority that has been granted by an all-sovereign God to human beings alone. 

Romans 13:1-7; Acts 10:35; 1 Peter 2:13-14

Article 10: War

We affirm that the use of AI in warfare should be governed by love of neighbor and the principles of just war. The use of AI may mitigate the loss of human life, provide greater protection of non-combatants, and inform better policymaking. Any lethal action conducted or substantially enabled by AI must employ 5 human oversight or review. All defense-related AI applications, such as underlying data and decision-making processes, must be subject to continual review by legitimate authorities. When these systems are deployed, human agents bear full moral responsibility for any actions taken by the system.

We deny that human agency or moral culpability in war can be delegated to AI. No nation or group has the right to use AI to carry out genocide, terrorism, torture, or other war crimes.

Genesis 4:10; Isaiah 1:16-17; Psalm 37:28; Matthew 5:44; 22:37-39; Romans 13:4

Article 9: Security

We affirm that AI has legitimate applications in policing, intelligence, surveillance, investigation, and other uses supporting the government’s responsibility to respect human rights, to protect and preserve human life, and to pursue justice in a flourishing society.

We deny that AI should be employed for safety and security applications in ways that seek to dehumanize, depersonalize, or harm our fellow human beings. We condemn the use of AI to suppress free expression or other basic human rights granted by God to all human beings.

Romans 13:1-7; 1 Peter 2:13-14

Article 8: Data & Privacy

We affirm that privacy and personal property are intertwined individual rights and choices that should not be violated by governments, corporations, nation-states, and other groups, even in the pursuit of the common good. While God knows all things, it is neither wise nor obligatory to have every detail of one’s life open to society.

We deny the manipulative and coercive uses of data and AI in ways that are inconsistent with the love of God and love of neighbor. Data collection practices should conform to ethical guidelines that uphold the dignity of all people. We further deny that consent, even informed consent, although requisite, is the only necessary ethical standard for the collection, manipulation, or exploitation of personal data—individually or in the aggregate. AI should not be employed in ways that distort truth through the use of generative applications. Data should not be mishandled, misused, or abused for sinful purposes to reinforce bias, strengthen the powerful, or demean the weak.

Exodus 20:15, Psalm 147:5; Isaiah 40:13-14; Matthew 10:16 Galatians 6:2; Hebrews 4:12-13; 1 John 1:7 

Article 7: Work

We affirm that work is part of God’s plan for human beings participating in the cultivation and stewardship of creation. The divine pattern is one of labor and rest in healthy proportion to each other. Our view of work should not be confined to commercial activity; it must also include the many ways that human beings serve each other through their efforts. AI can be used in ways that aid our work or allow us to make fuller use of our gifts. The church has a Spirit-empowered responsibility to help care for those who lose jobs and to encourage individuals, communities, employers, and governments to find ways to invest in the development of human beings and continue making vocational contributions to our lives together.

We deny that human worth and dignity is reducible to an individual’s economic contributions to society alone. Humanity should not use AI and other technological innovations as a reason to move toward lives of pure leisure even if greater social wealth creates such possibilities.

Genesis 1:27; 2:5; 2:15; Isaiah 65:21-24; Romans 12:6-8; Ephesians 4:11-16

Article 6: Sexuality

We affirm the goodness of God’s design for human sexuality which prescribes the sexual union to be an exclusive relationship between a man and a woman in the lifelong covenant of marriage.

We deny that the pursuit of sexual pleasure is a justification for the development or use of AI, and we condemn the objectification of humans that results from employing AI for sexual purposes. AI should not intrude upon or substitute for the biblical expression of sexuality between a husband and wife according to God’s design for human marriage.

Genesis 1:26-29; 2:18-25; Matthew 5:27-30; 1 Thess 4:3-4

Article 5: Bias

We affirm that, as a tool created by humans, AI will be inherently subject to bias and that these biases must be accounted for, minimized, or removed through continual human oversight and discretion. AI should be designed and used in such ways that treat all human beings as having equal worth and dignity. AI should be utilized as a tool to identify and eliminate bias inherent in human decision-making.

We deny that AI should be designed or used in ways that violate the fundamental principle of human dignity for all people. Neither should AI be used in ways that reinforce or further any ideology or agenda, seeking to subjugate human autonomy under the power of the state.

Micah 6:8; John 13:34; Galatians 3:28-29; 5:13-14; Philippians 2:3-4; Romans 12:10

Article 4: Medicine

We affirm that AI-related advances in medical technologies are expressions of God’s common grace through and for people created in His image and that these advances will increase our capacity to provide enhanced medical diagnostics and therapeutic interventions as we seek to care for all people. These advances should be guided by basic principles of medical ethics, including beneficence, non-maleficence, autonomy, and justice, which are all consistent with the biblical principle of loving our neighbor.

We deny that death and disease—effects of the Fall—can ultimately be eradicated apart from Jesus Christ. Utilitarian applications regarding healthcare distribution should not override the dignity of human life. Fur- 3 thermore, we reject the materialist and consequentialist worldview that understands medical applications of AI as a means of improving, changing, or completing human beings.

Matthew 5:45; John 11:25-26; 1 Corinthians 15:55-57; Galatians 6:2; Philippians 2:4

Article 3: Relationship of AI & Humanity

We affirm the use of AI to inform and aid human reasoning and moral decision-making because it is a tool that excels at processing data and making determinations, which often mimics or exceeds human ability. While AI excels in data-based computation, technology is incapable of possessing the capacity for moral agency or responsibility.

We deny that humans can or should cede our moral accountability or responsibilities to any form of AI that will ever be created. Only humanity will be judged by God on the basis of our actions and that of the tools we create. While technology can be created with a moral use in view, it is not a moral agent. Humans alone bear the responsibility for moral decision making.

Romans 2:6-8; Galatians 5:19-21; 2 Peter 1:5-8; 1 John 2:1

Article 2: AI as Technology

We affirm that the development of AI is a demonstration of the unique creative abilities of human beings. When AI is employed in accordance with God’s moral will, it is an example of man’s obedience to the divine command to steward creation and to honor Him. We believe in innovation for the glory of God, the sake of human flourishing, and the love of neighbor. While we acknowledge the reality of the Fall and its consequences on human nature and human innovation, technology can be used in society to uphold human dignity. As a part of our God-given creative nature, human beings should develop and harness technology in ways that lead to greater flourishing and the alleviation of human suffering.

We deny that the use of AI is morally neutral. It is not worthy of man’s hope, worship, or love. Since the Lord Jesus alone can atone for sin and reconcile humanity to its Creator, technology such as AI cannot fulfill humanity’s ultimate needs. We further deny the goodness and benefit of any application of AI that devalues or degrades the dignity and worth of another human being. 

Genesis 2:25; Exodus 20:3; 31:1-11; Proverbs 16:4; Matthew 22:37-40; Romans 3:23

Article 1: Image of God

We affirm that God created each human being in His image with intrinsic and equal worth, dignity, and moral agency, distinct from all creation, and that humanity’s creativity is intended to reflect God’s creative pattern.

We deny that any part of creation, including any form of technology, should ever be used to usurp or subvert the dominion and stewardship which has been entrusted solely to humanity by God; nor should technology be assigned a level of human identity, worth, dignity, or moral agency.

Genesis 1:26-28; 5:1-2; Isaiah 43:6-7; Jeremiah 1:5; John 13:34; Colossians 1:16; 3:10; Ephesians 4:24