Moderna on Hot Wheels this Winter

Rajee H. Singhania

Image credit: Polina Tankilevitch

Moderna, from a Mass. based biotech company, is the second vaccine after Pfizer to receive authorization ever since the FDA panel voted 20-0 for its emergency use on Thursday. Later, the CDC advisory committee also recommended it for use in people from 18 years of age.

The federal government has ordered 2,50,000 doses of Moderna in a single day and has plans to provide 5.9mn doses this week across 3,700 locations. Its distributor- McKesson Corp., has tied up with United Parcel Service (UPS) and FedEx to deliver these vaccines along with kits that contain needles and syringes. So far 100 million doses have been ordered at the cost of $15 per dose. Each dose contains 100 micrograms of the vaccine.

CVS Health Corp. and Walgreens Boots Alliances have been chosen to conduct vaccination for nursing homes and long-term care facilities. This entire project, including deliveries for other approved vaccines, comes under the Operation Warp Speed (OWS) which is a public-private partnership initiated by the U.S. government. Their goal is to produce and deliver 300 million doses of vaccines with the initial doses available by January 2021.

Their short-term projection is that of over 10 million vaccine doses by Christmas. It is to be, however, noted that the OWS is known to frequently revise its targets. This Saturday, General Gustave Perna, a co-leader of OWS, admitted to overestimating the figures which left many states like California, Colorado, Michigan and Georgia with 30 - 40% fewer doses of Pfizer than previously expected.

Contemplation over who should be vaccinated first; as vaccinating the old would mean fewer deaths and the young would mean fewer infections; finally reached its conclusion as the CDC on Sunday voted for adults aged 75 and older and essential workers to be vaccinated in phase 1B, and adults between 65 - 75 years and those between 16 - 64 years of age who are at high risk, and other essential workers in phase 1C.

During Modernas’ trial phase that involved receiving two doses three weeks apart, volunteers reported common symptoms such as fever, fatigue and muscle aches. One patient reported serious reactions. On September 17, Luke Hutchison, 44, said he had full-on COVID-like symptoms after the second shot that included fever, chills, muscle and joint aches, really hot hands and feet, headache, general malaise and cough.

Previously the U.S. had four companies in the final stage of testing: Moderna, Pfizer, AstraZeneca (AZ) and Johnson & Johnson (J&J). All of them had reported side effects. In August AZ and J&J had to stop their last-stage testing after several volunteers fell ill. However, in October they resumed again when no link could be established between their reactions and the vaccine.

According to Dr. Fauci, additional vaccine candidates are essential to meet the demand in the U.S. When asked which vaccine he would choose to take, he said he had no preference and would take whatever is available that time. He predicts the U.S. will reach herd immunity between March - April and cautioned that the vaccines in no way would reduce the importance of wearing face masks and observing social distancing.

Moderna had requested an emergency use authorization on the last day of November. Bancel, its CEO, called his vaccine a ‘gamechanger’ with 94.5% effectiveness in preventing COVID-19. Unlike Pfizer, Moderna can be stored at regular freezer temperatures and optimizes on shipment capacity: One consignment of Moderna contains 100 doses, compared to 975 of Pfizer.

Moderna, headquartered in Cambridge, Mass., manufactures these doses in Norwood, New Hampshire and Switzerland. Here’s a brief timeline of their journey since Jan 2020-

Jan 11 - Chinese authorities share genetic sequence of Covid-19

Jan 13 - NIH and Moderna finalize sequence for mRNA-1273

Feb 7 - First clinical batch gets completed

Mar 04 - FDA allows for clinical trials

Mar 23 - Moderna scales up manufacturing to produce millions of doses per month

Mar 27 - Emory University in Atlanta begins enrolling volunteers for Phase 1 trial

Apr 27 - Moderna submits to FDA for Phase 2 study

May 12 - Moderna receives FDA Fast Track designation

May 18 - Moderna announces positive interim Phase 1 data

May 29 - participants are dosed in Moderna’s Phase 2 study

July 27 - Phase 3 study begins

Aug 11 - Moderna agrees to supply the U.S. government with 100 million doses

Oct 22 - Moderna completes enrollment for Phase 3

Nov 16 - Phase 3 study shows vaccine efficacy of 94.5%

Dec 18 - FDA grants emergency approval for Moderna

Modernas' vaccine shot comes at a time when the total number of deaths in America has crossed 3,00,000 (highest for any country in the world), including that of a 'healthy' 29-year-old Veronica Gutierrez this Monday. The domestic demand for this jab is projected to only increase as experts recommend even those people who have defeated Covid-19 in the past to get vaccinated. The lack of cold storage facilities in the rural areas where the elderly population is high makes a certain section vulnerable to being left out. The pandemic has forced half of the rural hospitals to operate at a loss and very few can afford to buy freezers.

This inequality is also expected to manifest worldwide as poor countries would not be able to buy these vaccines at competitive prices. A section of their population may not see immunization until 2023. Low-risk people in the U.S. are likely to get vaccinated before the high-risk people in developing and underdeveloped countries. Out of the 10bn doses reserved, which in majority are purchased by high-income countries, 2.6bn is confirmed by the U.S. alone. Many countries had forged agreements with pharmaceutical companies even before the end of their clinical trials, resulting into panic buying. According to Andrea Taylor from Duke Global Health Innovation Center, the U.S. will probably have enough doses to vaccinate its population two times over and Canada, five times over.

Meanwhile, Moderna is being actively considered in the European Union (EU) as well and they are expected to reach a consensus on Jan 6. This will pave way for its use in over 27 countries. On Sunday EU authorized its first vaccine- Comirnaty, by BioNTech and Pfizer, for Covid-19 prevention. Over two weeks ago, more than 1,30,000 people in the U.K got vaccinated with Pfizer / BioNTech jabs. Currently the U.K has imposed new restrictions as a more contagious form of Covid-19 virus has been reported. Many EU nations have banned flights from Britain. However, the efficacy of these vaccines for the new strain of virus should remain unaffected in the opinion of experts.

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Hi, I am a 35-year-old wife and a mother to a 2yr old. Originally from Mumbai, India, I have recently made the US my home. For the last 12years I have been writing articles for increasing public awareness on issues of national interest and some other topics that pique my personal interest. In this process I have published a few books. My debut novel being- Love in a Time Machine, under the pen name- Minoo.

Greensboro, NC

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