Covid-19 Vaccines and Therapeutics: November Update
We have been stuck in our homes, able to get out only for essential runs to school or for more food to stress eat. Americans have been waiting for the United States government to approve a vaccine for nine months, while Russia, China, and the United Arab Emirates already have given the green light to Covid-19 vaccines. However, even though these countries have a government-approved vaccine, it was without the completion of a Phase 3 clinical trial. In addition, there is a limited supply of vaccines, so those governments cannot distribute the vaccine to their general population, instead targeting a small, high-risk population to reduce Covid-19 infection and death rate.
A part of the Russian Ministry of Health launched clinical trials in June of a vaccine they called Gam-Covid-Vac. It is a combination of two adenoviruses that were engineered with a coronavirus gene. In August, President Putin announced that the vaccine had been approved and renamed it to Sputnik V before finishing all three phases of clinical trials. After facing international criticism and doubt, Russia later said that the approval was only a “conditional registration certificate.” On October 17, Phases 2 and 3 of the Russian vaccine were launched in India. On September 4, the government researchers published the results of their Phase 1 & 2 trial. These trials found that Sputnik V yielded antibodies to the coronavirus and only had mild side effects. There have been agreements for the vaccine to be supplied to Brazil, Mexico, and India.
In China, Sinovac Biotech is testing a vaccine called CoronaVac. During the Phase 1 & 2 trials, no severe side effects were found, yet the vaccine produced an immune response. Then the Phase 3 trials were launched in Brazil, Indonesia, and Turkey. It was reported that the Chinese government gave the CoronaVac an emergency approval for limited use in July. In October, authorities in the eastern Chinese city of Jiaxing announced they were giving CoronaVac to people in relatively high-risk jobs. Sinovac has been preparing to manufacture the vaccine for global distribution in early 2021.
In the United Arab Emirates (UAE), there are two Chinese Covid-19 vaccines that have been approved by their government. The Wuhan Institute of Biological Products developed an inactivated virus vaccine, which the Chinese government-owned company Sinopharm put into clinical tests. The Phase 1 & 2 trials showed that the vaccine was effective, producing antibodies and some minor side effects such as fever. They launched Phase 3 trials in the UAE in July, and in Peru and Morocco the following month. Sinopharm began testing a second inactivated virus vaccine, this one developed by the Beijing Institute of Biological Products. After running early clinical trials in China, they launched Phase 3 trials in the UAE and Argentina. Over the summer, the UAE government gave approval for the company to inject hundreds of thousands of people with Sinopharm’s two vaccines. In October, Sinopharm stated their plans for producing a billion doses a year. Then on September 14, the UAE gave emergency approval for Sinopharm’s vaccine for use in healthcare workers.
Back home in the United States, there are some Covid-19 vaccine updates. In September, the chief executive of Pfizer said the Phase 3 trial would deliver enough results as soon as October to show if the vaccine worked or not. To the surprise and pleasure of the medical and scientific communities, Pfizer recently announced that its vaccine yielded a 90% (and, after further analysis 95%) success rate. If the vaccine is authorized, Pfizer and BioNTech, a German company, expect to manufacture over 1.3 billion doses of their vaccine worldwide by the end of 2021. Shortly after the initial news from Pfizer, Moderna, an American company, revealed that its vaccine boasted 95% effectiveness. AstraZeneca, a British company, also reported that its vaccine ultimately achieved 90% effectiveness and did not require special refrigeration for storage. Johnson & Johnson announced on October 12 that it put its trial on pause to investigate an adverse reaction in a volunteer, but then trial resumed eleven days later. Despite the delay, the company expects to get results by the end of the year.
Novavax launched a Phase 3 trial in August, enrolling up to 15,000 volunteers in the United Kingdom. It could potentially deliver results by the start of 2021. A larger Phase 3 trial is in development to launch in the United States by the end of November. If the trials succeed, Novavax expects to deliver 100 million doses for use in the United States by the first quarter of 2021. In September, Novavax reached an agreement with the Serum Institute of India, a major vaccine manufacturer, to produce as many as 2 billion doses a year.
Vaccines are used to prevent healthy individuals from being infected by Covid-19. When a person becomes infected with Covid-19, they need a therapeutic that develops antibodies more immediately than a vaccine. There have been new updates in the development of Covid-19 therapeutics. Regeron halted their trials in hospitalized patients because their therapeutic was found to be most effective during the mild stage of disease. The company approached the Food and Drug Administration (FDA) for an emergency use authorization. Regeneron’s monoclonal-antibody-cocktail that was given to President Trump is now in short supply. The method of developing these antibodies is to take Chinese hamster ovary cells and use them to grow Covid-19 antibodies. It takes 3 to 4 months in total to make these antibody cocktails. As of right now, they have around 50,000 available doses, and are predicted to have 300,000 early next year and 2 million by the end of next year. To increase production capacity, Regeneron has partnered with Roshe.
Another company, Eli Lilly, has also been racing to get the FDA to approve their Covid-19 therapeutic. Eli Lilly’s therapeutic was taken by Chris Christie, a former New Jersey governor. They have two antibodies currently running in multiple trials. One antibody is simultaneously in a trial for itself and a trial in combination with another antibody. The antibody mix seems to be doing better and is possibly more effective. Likewise, Eli Lilly has partnered with Amgen to increase manufacturing capacity.
While vaccines and therapeutics target the SARS-CoV-2 virus itself, anti-inflammatory drugs are thought to reduce the overactivation of the immune system from Covid-19. For example, dexamethasone was approved by the FDA for emergency use. A possible therapeutic is baricitinib, also an anti-inflammatory drug, used for rheumatoid arthritis patients. Baricitinib, an Eli Lilly drug, in combination with Remdesivir, made by Gilead and taken by President Trump, reduces time to recovery in hospitalized patients with Covid-19. The study showed that there was a one-day reduction in median recovery time for the overall patient population treated with Baricitinib and Remdesivir versus those treated with only remdesivir. In the United States, Baricitinib is approved for rheumatoid arthritis patients at a 2-mg daily dose; an emergency use authorization would potentially authorize a 4-mg dose for Covid-19.
A drug by Roche/Genentech, Tocilizumab, a mono-clonal antibody, anti-inflammatory drug also used for treating rheumatoid arthritis patients, was found to be effective for Covid-19 in a retrospective, observational study. On the other hand, a randomized, controlled, clinical trial showed that Tocilizumab was ineffective for preventing intubation or death in moderately ill hospitalized patients with Covid-19. Early on in the pandemic, hydroxychloroquine, yet another anti-inflammatory drug, originally used for treating lupus patients, was touted as a potential cure. But later on, a number of large, controlled, clinical trials failed to show any benefit from taking hydroxychloroquine, while the side effects could be harmful, even deadly.
Around the world, there have been many scientific advancements for the prevention and treatment of Covid-19. Hopefully, the vaccines will end the pandemic, and therapeutics and anti-inflammatory drugs will reduce the hurt and suffering Covid-19 patients are going through. However, very few vaccines are 100% effective, so keep in mind that we cannot expect the pandemic to disappear all of a sudden upon the arrival of a vaccine. Everyone is looking forward to the day where we no longer have to wear masks and socially distance, but please know that it may take some time for the pandemic to subside. So, please continue to wear masks, stay away from larger groups, and stay six feet apart to help reduce further suffering.