FDA Offers Emergency Use Authorization For Two Vaccines to Combat Covid-19

The FDA approved emergency use of two vaccines, one by Pfizer and one by Moderna to combat Covid-19

Pfizer and Moderna Vaccines to Prevent Covid-19

“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day.”

— Stephen M. Hahn, M.D and FDA Commissioner

On Dec 11, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for a vaccine to prevent the coronavirus disease 2019 (COVID-19) that is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) . The vaccine is approved for use in individuals aged 16 years of age and older. This emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine, manufactured by the pharmaceuticals company Pfizer Inc. to be distributed in the U.S.

A week later, the FDA also approved an EUA for the vaccine developed by Moderna, another pharmaceutical company. The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. After a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but instead, triggers the immune system to learn to react defensively, producing and developing an immune response against SARS-CoV-2.

While approving emergency use of both vaccines, the FDA also warned that the FDA does not have any FDA-approved vaccines and that taking this vaccine, while recommended, may not protect everyone. Still the clinical success rates are much higher than standard issue vaccines that hover around 70%. Clinical trials had initially shown a 95% success rate for the Pfizer vaccine and 94.1% success rate for the Moderna vaccine, giving researchers more confidence in recommending the vaccine for use.

Both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine are administered as a 2-dose series, 3 weeks apart, into the muscle.

Covid-19 Symptoms

COVID-19 disease is caused by a coronavirus called SARS-CoV-2, which has not been seen before. You can get COVID-19 through contact with another person who has the virus. Primarily a respiratory illness that can affect other organs, COVID-19 has results in varying symptoms in people from mild to severe illness. Symptoms do not appear immediately showing up 14 days after infection or exposure. Symptoms can include any of the following: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; and diarrhea.

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Side Effects of Taking a Vaccine

After receiving a second dosage of the vaccine, some recipients have reported side effects such as pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever.

More information is available on the FDA’s website and via this Pfizer PDF download and Moderna PDF download.

More data on the clinical trials are available at the New England Journal of Medicine.

Apple's Ongoing Response to COVID-19

From closing Apple retail stores outside China till March 27 to working remotely and even hosting WWDC online this year, Apple is taking numerous steps to mitigate risks posed by the spread of the coronavirus

Image via Apple

When news of the coronavirus COVID-19’s contagious spread from Wuhan, China to the rest of the world, Apple among other companies with a large presence in China was quick to take action. Now two months later since the Chinese government publicly announced the spread of COVID-19, many areas in China that were closed down have now reopened for business. However, as the virus continues to spread at an alarming rate around the globe, with fatalities, Apple has preemptively closed down all of its retail locations from Apple stores to associated warehouses outside of China till March 27th of this year. This shut down may last longer if the situation does not improve. More than 60 other retailers have also temporarily shut down to stop the community spread of the coronavirus, including well known and popular retailers from Nike to Sephora, L.L. Bean, J.Crew, Bloomingdale’s and more, according to Business Insider. Given the evolving nature of this situation, Apple has also issued a statement available on the home page of its website Apple.com.

“Our retail stores are closed until further notice. We are committed to providing exceptional service to our customers. For purchases with fast and free delivery, shop here on apple.com or the Apple Store app. For service and support, go to support.apple.com or call 800-275-2273. We look forward to seeing you soon.”

— Apple

Image via Apple

Apple’s Worldwide Developers Conference (WWDC) will be held online only this year and be entirely digital. Numerous other large events from SXSW to football games have also been canceled as organizers and local government aim to prevent the easy spread of the virus in community settings.

Apple’s stock AAPL took a hammering with the advent of the coronavirus COVID-19 in mid February, which the company forewarned in its investor guidance report earlier this year. Apple is not alone in facing this crisis, as the effects of the spread of the coronavirus COVID-19 has led to a shutdown in operations for many companies worldwide. Stock indices from Dow Jones to the NASDAQ initially plunged in response, with concerns of a potential economic recession underway. The effects of being part of an interconnected global economy with its upsides and downsides, could be felt across all stock indices.

The Federal Reserve has cut interest rates down to zero and injected capital into the economy to prevent this. Other economic measures in discussion include a stimulus package to provide some income for Americans who are unable to work during this period as areas for community gatherings are being shut down to prevent the virus’s spread; and a potential payroll tax cut. WSJ reported that the federal government seeks to send $1,000 checks to Americans as part of the $850 billion stimulus package proposed by the White House. The White House also released its guidelines for self-care and protection against the coronavirus, in accordance with the Center for Disease Control (CDC) guidelines. Individual states are also taking measures such as delaying collections on late bills for utilities in colder regions of the country such as Vermont to ensure residents have access to electricity and heat, and requiring “shelter in place” to restrict the spread of the disease in the San Francisco Bay Area. Stocks have now rebounded with news of a potential stimulus plan, with the Dow Jones increasing by as much as 1,000 points.

Apple’s stock has rebounded since then, showing an uptick as of March 17, 2020.

Companies like Google have moved their entire North American workforce to working remotely to prevent the spread of the virus. Google offers tips on productivity and numerous free tools to encourage collaboration and prevent isolation. Remote work has its challenges, but many companies ranging from Amazon to Twitter, AirBnB, Facebook, Microsoft and more are moving their workforce online as best as possible, according to CNN Business. Apple has also been making this shift, although it has proved challenging in some areas that require on-site work. Apple has also been rapidly updating its remote learning and device management options.

While the virus spread seems to have slowed down both in China and South Korea where the highest numbers of cases were initially reported, COVID-19 continues to spread around the globe. John Hopkins University’s Systems Science and Engineering (CSSE) reported over 196,639 confirmed cases, with 80,840 recoveries and 7,893 deaths as of March 17, 2020. COVID-19 has been declared a global pandemic by the World Health Organization (WHO) given how easily the disease is spread and since there is no known cure yet. The first clinical trials for a vaccine developed by Kaiser Permanente are now underway in Seattle, WA, according to CBS News. Scientists worldwide are hard at work on developing a suitable vaccine.