Blood Plasma Of Recovered COVID-19 Patients Approved By US FDA For Investigational Use As Treatment
Technician separates blood components into plasma, platelets, and red blood cells.

The US Food and Drug Administration granted investigational emergency use approval for convalescent blood plasma as a potential COVID-19 treatment on Tuesday. 

Cloned antibodies from recovered COVID-19 patients showed impressive ability to neutralize SARS-CoV-2, the virus behind the disease, in cell cultures, according to a paper published Wednesday on the preprint server BioRxiv. Two of the most potent antibodies isolated, 299 P2C-1F11 and P2B-2F6, were able to bind so strongly to the virus that it reduced the percentage of virus attaching to live cells by almost 100%. 

Patients who have recovered from COVID-19 have antibodies in their blood that might be effective against the infection. These antibodies, found in the blood plasma – or the transparent, liquid part of the blood – could be then injected into COVID-19 patients to provide some immunity as the host immune system ramps up its own response.

Early evidence from a Chinese trial in 10 patients showed “significant improvement” within 1 to 3 days after receiving a blood plasma transfusion, with 2 of the 3 patients weaned off mechanical ventilation shortly after the transfusion.

New York State, which has about half of the 62,873 COVID-19 cases in the United States, is set to roll-out the first treatments within the next week, Governor Andrew Cuomo said on Monday. According to CNN, New York will be first recruiting recovered patients from New Rochelle, which saw the first cluster of cases in the state and thus has the largest cluster of recovered COVID-19 patients eligible to donate blood. 

Although promising, convalescent blood plasma is not effective for every disease, says the US FDA, including for viral diseases such as Ebola. Success in cell culture studies must still be replicated in human patients. However, experts have been pushing since January for more serious consideration of such treatment as a potential COVID-19 treatment, based on limited success in treating other coronaviruses, such as SARS and MERS.

Under US FDA regulations, the treatment is only available to patients with a lab confirmed positive COVID-19 test experiencing severe disease, and enrolled in a clinical trial. 

A recovered patient with a prior lab-confirmed COVID19 diagnosis may donate blood plasma 2 weeks after their symptoms resolve, and only if they then test negative for COVID-19. 

The collected blood plasma can then be immediately infused into COVID-19 patients with severe disease, after the donation is screened for other blood-borne diseases.

Other trials of blood plasma or plasma-derived products are already taking place at the University of Washington in St. Louis, Missouri. Scientists there submitted a  investigational new drug application to the FDA on 18 March. In a related development, the pharma firm Takeda announced on 4 March that the company initiated development of an antibody treatment derived from plasma. 

61 Organizations Call On EU To Ensure Accessibility of New Coronavirus Products

Some 61 NGOs released an open letter on Wednesday calling on the European Union and national governments to incorporate access and affordability products into approvals for new COVID-19 products. The groups also said that governments should exclusive licensing, and require disclosure of public contributions to drug development as part of COVID-19 research.

“In the current pandemic situation when time is of the essence and it is critical that any treatment developed with public funds is made as widely available as possible, the call for greater transparency and accountability for public funds used in biomedical R&D is particularly pertinent,” said Jaume Vidal, senior policy advisor at Health Action International, the access organization that coordinated the letter, in an interview with Health Policy Watch.

Vidal added that making COVID-19 drugs as widely available as possible “necessarily entails” affordability requirements, and that the ask on non-exclusive licensing was a “specific demand to counter” medicines shortages, which can be caused by limiting the number of producers. 

A recent fast-track US $45 million call for proposals on developing therapeutics and diagnostics for COVID-19 by the Innovative Medicine Initiative (IMI) did not require affordability clauses, according to the letter. Affordability clauses help ensure that any successful products developed by grant money are not priced out of reach of low- or middle-income countries, or poorer health systems. 

Additionally, the NGOs said that granting exclusive licenses for successful COVID-19 product should not be allowed, just days after the US FDA granted Gilead’s remdesivir, a promising coronavirus antiviral, “orphan drug” status – giving the pharma company 7 years of US market exclusivity.

However in an unusual about-face, the company requested the FDA rescind the “orphan drug” designation on Wednesday after facing a public backlash from medicines access advocates.

The open letter said that market exclusivity on COVID-19 products could create “excessively high prices or over-reliance on a single source, which can increase the possibility of shortages.

“An effective response requires that all these necessary medical tools are free of charge at the point of delivery, particularly for vulnerable populations,” the organizations stated in the letter.

Europe Remains the Epicentre, But Some Countries Can Still Stem the Tide.

The letter was released as active cases in Europe surged to 197,842 cases and 12,822 total deaths. Italy and Spain remain the worst affected countries with 54,030 and 40,382 active cases respectively; however, Switzerland with 9765 cases has now overtaken Italy to have the highest number of cases per capita. 

In Italy, fatalities rose to 743 deaths, after several days of lower numbers. Prime Minister Giuseppe Conte increased fines for leaving homes to up to 3,000 euros from the previous maximum of 206 euros. In Spain, an ice rink in Madrid has been converted into a temporary morgue, according to El Paiz.

Meanwhile, across the Atlantic, cases shot up in the United States to 62,873, with 30,811 alone in New York State. The uptick of cases in the state is also driven by increased testing. The state is testing more than 16,000 people a day, a higher per capita testing rate than even China or South Korea, according to a press release from Governor Andrew Cuomo’s office. However, other states in the US are still facing test kit shortages – amid mixed messages from the White House on whether most US workers will be able to return to their jobs again by Easter.

In Latin America, Brazil remains the most affected country at 2155 cases followed by Chile with 903 and Ecuador with 775 cases. As the number of cases escalates in Chile, the government is facing pressure to introduce a national lockdown, following in Argentina’s footsteps, according to National Public Radio. Chilean President Sebastian Piñera has declared the situation as “a state of catastrophe” and has deployed the armed forces to maintain infrastructure and supply lines. 

According to the latest WHO situation report, the total number of cases in the WHO African Region is 1305 -315 more than the previous day – and deaths increased from 23 to 26. South Africa, Algeria and Burkina Faso are the most affected countries in the region with 402, 231 and 99 cases respectively. President of the Democratic Republic of the Congo Felix Tshisekedi declared a “state of emergency” Wednesday morning as the case count hit 45 cases and 3 deaths, closing country borders and banning all flights, even domestic ones, from entering Kinshasa, in an attempt to lock down the country’s dense urban center.

However, according to World Health Organization Director General Dr Tedros Adhanom Ghebreyesus, around the world more than 150 countries still have less than 100 cases – and those nations still had a chance to prevent widespread disruptions from COVID-19.

“Aggressive measures to find, isolate, test, treat and trace are not only the best and fastest way out of extreme social and economic restrictions – they’re also the best way to prevent them,” said Dr Tedros.

Active cases around the world as of 11PM CET 25 March. Right column shows cumulative case count. Numbers are rapidly changing.

This story was updated 27 March 2020.

Image Credits: Banc de Sang i Teixits, Johns Hopkins CSSE.