On Dec. 11, 2020, Peru’s National Institute of Health (INS) said it was temporarily suspending the Phase 1 clinical trial of an experimental COVID-19 vaccine developed by Sinopharm Group Co. Ltd. of Shanghai, China after one of the participants in the trial who got the vaccine showed difficulty in moving his arms and legs—symptoms of Guillain-Barré syndrome (GBS).1 2 3 4 5
Peru’s Health Service Suspends Clinical Trial of Sinopharm COVID-19 Vaccine
“Several days ago we signaled, as we are required, to the regulatory authorities that one of our participants (in trials) presented neurological symptoms which could correspond to a condition called Guillain-Barre syndrome,” said German Malaga, MD, chief researcher at Cayetano Heredia University in Lima, Peru, where the vaccine trial is being conducted. “We are concerned about the situation, and we are providing all of our help and support to ensure that it is cleared up,” he said.1 2 3
Guillain-Barre Syndrome After Vaccination
During 1976, as part of a campaign by the U.S. government to vaccinate Americans against a novel type A strain of the influenza virus known as H1N1 (“swine flu”), 450 people in the United States developed Guillain-Barre syndrome (GBS), which involved inflammation of the peripheral nervous system and can cause temporary or permanent paralysis that can be fatal.1 2 6
According to referenced information on the website of the National Vaccine Information Center (NVIC) at NVIC.org:
One of the most serious documented influenza vaccine reactions is Guillain-Barre syndrome (GBS). An immune mediated painful and disabling neurological disorder that can occur after viral infection or vaccination, GBS involves inflammation of the peripheral nervous system and can cause temporary or permanent paralysis that may lead to death. GBS usually develops within two to four weeks of vaccination.7
NVIC notes that GBS is characterized by “muscle weakness, unsteady gait, numbness, tingling, pain.” It can cause “paralysis of the face or one or more limbs” and can take “several months for recovery or it can leave the affected person with chronic health problems and disability.”7
The U.S. Food and Drug Administration (FDA) lists GBS as one of 22 possible “adverse events outcomes” that are being monitored after people receive new COVID-19 vaccinations.8 The other vaccine adverse events on the FDA’s surveillance list include:
- acute disseminated encephalomyelitis
- transverse myelitis
- narcolepsy and cataplexy
- acute myocardial infarction
- autoimmune disease
- pregnancy and birth outcomes
- other acute demyelinating diseases
- non-anaphylactic allergic reactions
- disseminated intravascular coagulation
- venous thromboembolism
- arthritis and arthralgia/joint pain
- Kawasaki disease
- multisystem inflammatory syndrome in children
- vaccine enhanced disease.
Sinopharm’s COVID-19 Vaccine Uses Killed Virus
Unlike COVID-19 vaccines produced by companies such as Pfizer, Inc. (and its partner BioNTech SE) and Moderna, Inc. that rely on a novel vaccine technology that uses synthetic messenger RNA (mRNA) designed to instruct cells in the human body to produce proteins and stimulate the production of SARS CoV-2 antibodies, Sinopharm’s COVID-19 vaccine uses traditional vaccine technology incorporating a killed SARS CoV-2 virus to deliver the vaccine.9
Suspension is Lifted
Peruvian health minister Pilar Mazzetti, MD announced on Dec. 16 that Sinopharm could resume its clinical trial in Peru even though it was unclear why the trial volunteer developed GBS. “We have had several meetings with Sinopharm and the suspension has been lifted,” Dr. Mazzeti said.10
Click here to view References:
1 Peru suspends clinical trials of Chinese COVID vaccine. Medical Xpress Dec. 12, 2020.
2 AFP. Peru suspends clinical trials of Chinese Covid vaccine. France 24 Dec. 12, 2020.
3 Dube R. Peru Halts Trial for Chinese Covid-19 Vaccine. The Wall Street Journal Dec. 13, 2020.
4 Reuters. Peru suspends China’s Sinopharm Covid-19 vaccine trial after ‘serious adverse event’. The Straits Times Dec. 12, 2020.
5 Reuters Staff. Peru suspends Sinopharm COVID-19 vaccine trial after “adverse event”. Reuters Dec. 12, 2020.
6 Kreston R. The Public Health Legacy of the 1976 Swine Flu Outbreak. Discover Sept. 30, 2013.
7 Influenza Overview. National Vaccine Information Center.
8 Anderson S. CBER Plans for Monitoring COVID-19 Vaccine Safety and Effectiveness. U.S. Food and Drug Administration, VRBPAC Meeting. Oct. 22, 2020.
9 Israel’s Netanyahu: Vaccination campaign to begin Dec. 27. Associated Press Dec. 9, 2020.
10 Reuters. Peru says China’s Sinopharm may resume coronavirus vaccine trial after volunteer’s illness. Yahoo! News Dec. 16, 2020.